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"Non injectables": methadone syrup and benzodiazepine injection by methadone-maintained clients.

To obtain more information about anecdotal reports of injection of methadone syrup and benzodiazepine drugs among injecting drug users, interviews were conducted with 32 subjects as part of a larger study into drug use patterns of clients in methadone maintenance treatment. Subjects were asked about frequency of injection of methadone and benzodiazepines, reasons for injection and methods of preparation for injection. The study found that 78% had injected methadone and 25% had injected benzodiazepines at some time during their drug using careers. Service providers can play an important role in promoting harm minimization strategies, and utilizing behaviour modification techniques.

Journal Article↗

The crossflow injection technique: an improvement of the ethanol injection method.

A novel scalable liposome preparation technique for pharmaceutical application is presented. Previous experiments have shown that the concept of continuous crossflow injection is a promising approach. For the characterization of the process, we focus on the influencing parameters like the lipid concentration, the injection hole diameter, the injection pressure, the buffer flow rate, and system performance. These experiments demonstrate that the injection hole diameter and the system performance do not influence the vesicle forming process and that a minimum of buffer flow rate is required to affect batch homogeneity. In contrast, strongly influencing parameters are lipid concentration in combination with increasing injection pressures. After exceeding the upper pressure limit of the linear range, where injection velocities remain constant, the vesicle batches are narrowly distributed, also when injecting higher lipid concentrations. Reproducibility and scalability data show similar results with respect to vesicle size and size distribution and demonstrate the stability and robustness of the novel continuous liposome preparation technique.

1,2-Dipalmitoylphosphatidylcholine↗

Effect of timing of oocyte denudation and micro-injection on survival, fertilization and embryo quality after intracytoplasmic sperm injection.

In human in-vitro fertilization (IVF), the oocytes are surrounded by cumulus and corona cells at the time of insemination so that their maturity cannot easily be evaluated. The best IVF results are obtained if the oocytes are inseminated 2-6 h after retrieval. In the intracytoplasmic sperm injection (ICSI) procedure, the oocytes are denuded by enzymatic and mechanical treatment in order to be able to perform the injection. As a consequence, the nuclear maturity of the oocytes can be evaluated and only those that have extruded the first polar body are injected. However, metaphase-II oocytes that have not yet reached cytoplasmic maturity cannot be recognized. The purpose of this study was to investigate the effect of different timing of cumulus-corona cell removal and injection on the outcome of ICSI. For this we allowed the oocytes to complete in-vitro cytoplasmic maturation in two different culture conditions: (i) surrounded by their cumulus and corona cells or (ii) totally denuded. We performed three different studies on sibling oocytes obtained after a standardized buserelin/human menopausal gonadotrophin (HMG) protocol. We investigated the effect of early (1-2 h after retrieval) and late (5-6 h after retrieval) oocyte denudation and injection on the survival and fertilization of the injected oocytes and on embryo cleavage after fertilization. We found no statistically significant differences between early and late injection, indicating that after a standardized buserelin/HMG protocol the metaphase-II oocytes do not need time for further cytoplasmic maturation. Furthermore, a different timing of cumulus-corona cell removal has no effect on the outcome of ICSI, suggesting that the surrounding cells are not necessary for survival, fertilization and cleavage after ICSI.

Adult↗

Knowledge of HIV serostatus and preventive behaviour among European injecting drug users. The European Community Study Group on HIV in Injecting Drug Users.

OBJECTIVE: To study the effect of knowledge of HIV serostatus on behaviour for preventing the acquisition or transmission of HIV among European injecting drug users (IDU). METHODS: Data on behaviour and prior knowledge of HIV status were gathered during a multicentre cross-sectional survey of 200 European IDU recruited in 12 European countries in 1990. The respective proportions of IDU who (1) used condoms, (2) did not give their used injecting equipment to other IDU and (3) injected drugs safely (ether did not re-use other IDU's equipment or re-used it only after disinfection with bleach, alcohol or boiling water during the 6 months preceding interview were compared according to whether they knew their HIV serostatus for at least 6 months prior to interview. RESULTS: In comparison with IDU who had never been tested, IDU who knew that they were HIV-seropositive were more likely to always use condoms [rate ratio (RR) = 3.1; 95% confidence interval (CI), 2.3-4.2] and never gave their used equipment to other IDU (RR = 1.3; 95% CI, 1.2-1.5), but did not differ with regard to safe injecting practices (RR = 1.0; 95% CI, 0.9-1.1). Compared with IDU who had never been tested, IDU with a negative test tended to inject drugs safely more often (RR = 1.1; 95% CI, 1.02-1.2). There was no significant difference in condom use (RR = 0.7; 95% CI, 0.5-1.1). CONCLUSION: These results indicate that the knowledge of HIV serostatus may help to reduce HIV transmission from HIV-positive IDU to others through safer injecting and sexual behaviour. However, for HIV-negative IDU safer injecting behaviour appears to be better accepted than safer sexual behaviour.

Adult↗

The prevalence of additional injection-related HIV risk behaviors among injection drug users.

SUMMARY: This study assesses the prevalence of injection-related behaviors that may facilitate HIV transmission even when syringes are not directly shared. Subjects who self-reported practicing these "indirect sharing" behaviors are described, the prevalence of these behaviors are compared with the direct sharing of syringes, and variables independently associated with indirect sharing are determined. Injection-related risks were assessed among 585 injection drug users (IDUs) in Denver, Colorado. Respondents were classified into three groups based on their self-reported injection behaviors: IDUs who directly and indirectly share syringes, IDUs who indirectly share only, and IDUs who neither directly or indirectly share. Indirect sharing was twice as prevalent as direct sharing. IDUs who injected heroin or speedballs were less safe in their injection behavior than those who did not. Drug treatment did not protect against injection-related risk behaviors; however, exposure to community HIV prevention efforts was protective. Indirect sharing behaviors are common, yet their link to HIV transmission remains unrecognized by many IDUs. IDUs must be informed about these additional risk behaviors.

Adolescent↗

Trends in injection risk behaviors in a sample of New York City injection drug users: 1992-1995.

OBJECTIVES: This study assessed the relation between year of recruitment into an AIDS prevention project and likelihood of engaging (yes/no) in injection risk behaviors. METHODS: In total, 834 injection drug users were recruited over a 44-month period (January 1992-August 1995) in New York City. Logistic regression was used to examine trends in three behaviors, across four successive annual cohorts: using needles/syringes that were previously used by another person, using injection supplies (e.g., cookers, cotton, rinse water) that had been previously used, and giving or lending of used needles/syringes to another person. RESULTS: Significant (p < .0001) decreasing trends occurred in two behaviors: giving or lending of used needles/syringes to another person and use of injection supplies that had been used by another person. Sample characteristics were generally consistent over time and did not obviate significant injection risk trends. CONCLUSIONS: Decreasing trends in injection risk behaviors could not be explained by changing sample characteristics. Even though some injectors report engaging in risky injection practices, the confluence of numerous AIDS prevention efforts in the 1990s has contributed to an overall reduction in the likelihood of such behaviors.

Adult↗

The potential public health and community impacts of safer injecting facilities: evidence from a cohort of injection drug users.

BACKGROUND: Although medically supervised safer injecting facilities (SIFs) remain untested in North America, their implementation is currently being debated. Reluctance of health policy makers to initiate a pilot study of SIFs may in part be hindered by outstanding questions regarding the potential community and public health impact of the intervention. Specifically, it is presently unknown if those at greatest risk of overdose and HIV transmission or those responsible for community impact of injection drug use will be willing to attend. METHODS: The current study was conducted to evaluate the proportion of injection drug users (IDU) willing to attend medically supervised SIFs, if they were available, among participants enrolled in the Vancouver Injection Drug User Study (VIDUS). The authors also evaluated factors associated with willingness to use a SIF using univariate and logistic regression analyses. Participants who were followed from June 2001 to June 2002 were eligible for the present analyses. RESULTS: Overall, 587 active IDU responded to a questionnaire during the study period. Among respondents, 215 (36.6%) expressed willingness to attend a SIF. Variables that were independently associated with willingness to attend a SIF in multivariate analyses included having difficulty accessing sterile syringes (adjusted odds ratio [AOR] = 2.07), requiring help injecting (AOR = 1.52), frequently injecting heroin (AOR = 1.81), sex trade work (AOR = 2.02), and injecting in public spaces (AOR = 2.00). CONCLUSIONS: Several variables that have recently been associated with overdose, syringe sharing, HIV and HCV incidence, and community impact of illicit drug use in this setting were associated with willingness to attend medically supervised SIFs. Although the impact of SIFs in North America can only be quantified by scientific evaluation, these data indicate a high potential for immediate community and public health benefits if SIFs were presently available.

Adult↗

Progression of HIV infection in misusers of injected drugs who stop injecting or follow a programme of maintenance treatment with methadone.

OBJECTIVE: To see whether misusers of injected drugs who stop injecting or switch to a programme of maintenance treatment with methadone have a reduced risk of progression of HIV infection when compared with a group of persistent misusers. DESIGN: Observational cohort study in HIV seropositive subjects with a current or past history of misusing injected drugs. SETTING: HIV outpatient clinic at the University Hospital of Zurich, Switzerland. PATIENTS: 297 Current and former parenteral drug misusers (median age 27) with asymptomatic HIV infection. During the observation period 80 subjects adhered to a programme of maintenance treatment with methadone, 124 continued with parenteral drug misuse, and 93 former misusers remained free of illicit drugs. No antiretroviral treatment was given during the study. MAIN OUTCOME MEASURES: Probability of progression of HIV infection from asymptomatic to symptomatic (Centers for Disease Control stage IV) as calculated by life table analysis and compared in the three groups of patients by means of a log rank test, and predictors of disease progression as analysed with a Cox proportional hazards regression model. RESULTS: The 297 patients were followed up for a median of 16 months. The median duration of injecting drug misuse before enrollment was 7.1 years. There were no significant differences among the three groups with respect to CD4+ counts at the beginning of the study (median 0.44 x 10(9)/l). Life table analysis showed a significantly lower probability of progression of HIV disease in both the methadone treated group and former drug misusers than in persistent injecting drug misusers. Multivariate regression analysis showed a relative risk of progression of the disease of 1.78 (95% confidence interval 1.20 to 2.67; p less than 0.01) in persistent injecting drug misusers, 0.48 (0.29 to 0.77; p less than 0.01) in the methadone treated group, and 0.66 (0.41 to 1.06; p = 0.085) in former drug misusers. CONCLUSIONS: Stopping the misuse of injected drugs slows the progression of HIV disease in infected subjects. Drug treatment programmes are effective in secondary prevention of HIV associated morbidity.

Adult↗

Epinephrine injection therapy versus a combination of epinephrine injection and endoscopic hemoclip in the treatment of bleeding ulcers.

AIM: To assess the efficacy of hemoclip application in combination with epinephrine injection in the treatment of bleeding peptic ulcers and to compare the clinical outcomes between patients treated with such a combination therapy and those treated with epinephrine injection alone. METHODS: A total of 293 patients (211 males, 82 females) underwent endoscopic therapy for bleeding peptic ulcers. Of these, 202 patients (152 males, 50 females) received epinephrine injection therapy while 91 patients (59 males, 32 females) received combination therapy. The choice of endoscopic therapy was made by the endoscopist. Hemostatic rates, rebleeding rates, need for emergency surgery and 30-d mortality were the outcome measures studied. RESULTS: Patients who received combination therapy were significantly older (mean age 66+/-16 years, range 24-90 years) and more suffered from chronic renal failure compared to those who received epinephrine injection therapy alone (mean age 61+/-17 years, range 21-89 years). Failure to achieve permanent hemostasis was 4% in the group who received epinephrine injection alone and 11% in the group who received combination therapy. When the differences in age and renal function between the two treatment groups were taken into account by multivariate analysis, the rates of initial hemostasis, rebleeding rates, need for surgery and 30-d mortality for both treatment options were not significantly different. CONCLUSION: Combination therapy of epinephrine injection with endoscopic hemoclip application is an effective method of achieving hemostasis in bleeding peptic ulcer diseases. However, superiority of combination therapy over epinephrine injection alone, could not be demonstrated.

Adult↗

[Percutaneous injection of cisplatin lipiodol suspension (CLS) in rabbit lung, aiming at intratumoral injection therapy for lung cancer].

Cisplatin lipiodol suspension (CLS: cisplatin 20 mg/ml) was percutaneously injected (cisplatin dose, 2, 4 or 6 mg/kg) in normal lungs of 10 rabbits (1.9-2.3 kg) to assess the safety and feasibility of intratumoral injection of CLS for lung cancer. Histological study revealed acute and chronic infiltrates with bronchiolitis and immature fibrosis at the injected lung tissue even at four weeks after injection. Intrathoracic leaks of CLS produced mild and focal fibrinous pleuritis. Intrabronchial leaks of CLS produced peripheral bronchiolitis with regenerative epithelia. However, no noxious parenchymal damage in the lung and surrounding tissues was noted. Neither oil embolism in brain nor renal toxicity was demonstrated. Seven of eight rabbits showed an increase in body weight. Concentration levels of plasma platinum were lower when compared with intravenous injection of cisplatin in the rabbit: highest at 30 minutes and unmeasurable one week after injection. Lipiodol accumulation in mediastinal lymph nodes was demonstrated in two of nine rabbits by X-ray examination, suggesting intralymphatic drainage of CLS. Intratumoral injection of CLS is safe even with CLS leaks in surrounding normal lung tissues and may be a potent therapy for controlling mediastinal lymph nodes metastasized from lung cancer as well as the primary tumor.

Administration, Cutaneous↗

Grooming induced by intrahypothalamic injection of ACTH in the rat: comparison with grooming induced by intrahypothalamic electrical stimulation and i.c.v. injection of ACTH.

Intracerebroventricular (i.c.v.) injection of adrenocorticotropic hormone (ACTH) elicits grooming in the rat, but the neural organization of this response is still obscure. Electrical stimulation (EHS) in an area around the hypothalamic paraventricular nucleus (PVH) also elicits grooming. This hypothalamic area contains many ACTH-immunoreactive fibres. Injection of ACTH1-24 (0.3 microgram/0.3 microliters) in the same area elicits intense grooming responses in the rat. Latency, intensity and precise patterning of the grooming response are dependent upon the exact site of injection. Comparison of grooming responses elicited by EHS, ACTH injected i.c.v. and ACTH injected in the PVH reveals that these are slightly dissimilar. This may provide clues as to the brain mechanisms involved in the organization of the different components of grooming. EHS does not elicits scratching and even reduces 'spontaneous' scratching. Also, EHS-elicited grooming is characterized by short pauses. The time-course of appearance of yawning differs between ACTH-PVH and ACTH-i.c.v. injections. Excited locomotion elicited only by ACTH-i.c.v. is apparently caused by ACTH-sensitive systems outside the PVH. The results suggest that the ACTH-containing part of the hypothalamus around the PVH is crucially involved in the organization of grooming behaviour. We believe that at this level in the brain, the subroutines of grooming, scratching and yawning are integrated into one skin maintenance behaviour.

Adrenocorticotropic Hormone↗

[A four year follow-up study of recombinant HB vaccine--comparisons between three doses of subcutaneous injections and additional low dose intradermal injection].

To determine the efficacy of an additional low dose of intradermal injection of recombinant HB vaccine administered to nonresponders in addition to the standard three injections, we investigated the anti-HBs positive rate and titer of anti-HBs after four years among 58 subjects who did not develop antibodies after three doses of subcutaneous injections and who did develop the antibody after an additional low dose intradermal injection (Nonresponders), and compared them with 150 subjects who developed anti-HBs after three doses of subcutaneous injections (Responders). Fifty four subjects who were negative after four years were revaccinated with one or three doses of the subcutaneous injection. Anti-HBs positive rates after four years were 56.0 percent in Responders and 56.9 percent in Nonresponders, showing no differences. Eighty eight percent of 54 subjects who were given one or three doses of the vaccine developed anti-HBs. There were no differences in the antibody rates or titer of the antibody between the one and three doses groups. The decrease in titer of antibody was related to the levels initially having the most marked decrease in the level four years later. From these findings, we concluded that there were no differences of anti-HBs positive rates or antibody titer after four years in Responders and Nonresponders, and that one additional dose of the vaccine may be effective four years after initial administration among both groups.

Adult↗

A validation trial of subdermal injection compared with intraparenchymal injection for sentinel lymph node biopsy in breast cancer.

Sentinel lymph node (SLN) biopsy is increasingly being used as an accurate and less morbid surrogate for axillary dissection. However, a standardized technique in the biopsy of SLNs is not used. Some authors propose subdermal injection to be as accurate as peritumoral intraparenchymal injection (IPI). Our objective is to determine whether the SLNs identified by subdermal injection truly represent SLNs and match those found with IPI. Specific end points of the study were 1) successful localization of the SLN by the IPI of isosulfan blue or the radiocolloid intradermal injection, 2) successful uptake of radiocolloid and isosulfan blue on individual SLN, and 3) determination of the frequency with which the radiocolloid injection detected the "gold standard" blue SLN. SLNs were found in 71 of 73 cases (success rate = 97%). Blue SLNs were identified in 64 patients (88%). SLNs in 61 patients (84%) were radioactive. A total of 112 SLNs were identified in 71 patients (1.6 nodes/patient). Seventy-six of 87 SLNs found with IPI were also radioactive (concordance of 87%). All SLNs harboring metastatic cancer (16 patients) were found by both techniques, being both blue and radioactive. Our results support the concept of shared lymphatic pathways in the breast with a high degree of communication between the subdermal lymphatics and the intraparenchymal lymphatics. The success in identification of the SLN is made simpler and improved by the addition of subdermal radiocolloid injection.

Adult↗

Safety of radiofrequency treatment over human skin previously injected with medium-term injectable soft-tissue augmentation materials: a controlled pilot trial.

BACKGROUND AND OBJECTIVES: Several soft-tissue augmentation materials are now available for reduction of nasolabial fold creases and perioral rhytides. Nasolabial folds and perioral rhytides can also be improved by skin tightening delivered by non-ablative radiofrequency (RF) treatment. The purpose of this study was to assess the safety of RF treatment over skin areas recently injected with medium-term injectable soft-tissue augmentation materials. STUDY DESIGN/MATERIALS AND METHODS: Five subjects were assigned to the experimental arm (augmentation materials plus RF) and one to the control arm (augmentation materials alone). Each subject received injections of 0.3 mL of hyaluronic acid derivative (Restylane) and calcium hydroxylapatite (Radiesse) 3 cm apart on the upper inner arm. Two weeks later, two non-overlapping passes of RF (Thermage ThermaCool TC) were delivered at 63.5 setting with medium-fast 1.5 cm2 tip over injected sites in all of the experimental subjects. Punch skin biopsies were obtained 3 days later from each of the two injection sites on each subject. RESULTS: Light microscopy and digital photomicrographs obtained at low, medium, and high power showed no difference between filler materials in experimental and control subjects. In both cases filler was evident at the deep dermal-subcutaneous junction. Nodule formation, foreign body extravasation, or hemorrhage/clot was not observed grossly or histologically. Subjects and physicians did not report any difference in signs and symptoms between the experimental and control arms. Slightly increased transitory pain was noted when RF was delivered over filler versus over normal skin. CONCLUSION: Applying RF treatment over the same area 2 weeks after deep dermal injection with hyaluronic acid derivatives or calcium hydroxylapatite does not appear to cause gross morphological changes in the filler material or surrounding skin. Further studies with different parameters are necessary to confirm these findings.

Adult↗

Injecting 5-HT into the PVN does not prevent feeding induced by injecting 8-OH-DPAT into the raphe.

The selective 5-hydroxytryptamine1A (5-HT1A) agonist 8-hydroxy-2-(di-n-propylamino)tetralin (8-OH-DPAT) activates raphe somatodendritic autoreceptors, leading to an inhibition of 5-HT neuronal activity and reduced synthesis and release of 5-HT in forebrain terminal areas. One behavioural consequence of this is increased feeding in satiated rats. Because injections of 5-HT agonists into the medial hypothalamus suppress feeding, it has been proposed that 8-OH-DPAT-induced feeding may involve a reduction of 5-HT release within this area. This hypothesis was tested by examining the ability of 5-HT injected into the medial hypothalamus to reverse the feeding-stimulant action of 8-OH-DPAT following injection into the dorsal raphe or median raphe. Two groups of rats, maintained with free access to food at all times, were used. Each was prepared with two cannulae, one aimed at the paraventricular nucleus (PVN) of the medial hypothalamus and the other at either the dorsal raphe nucleus or median raphe nucleus. Food intake over the next hour was increased following dorsal raphe or median raphe injections of 8-OH-DPAT (1 and 0.5 microgram, respectively). These effects were not blocked by injections of 7.5 or 15 micrograms 5-HT into the PVN. However, 15 micrograms 5-HT did attenuate the feeding-stimulant action of 10 micrograms norepinephrine injected into the PVN. These results do not support the hypothesis that a reduction in 5-HT release within the medial hypothalamus is responsible for the feeding-stimulant action of 8-OH-DPAT.

8-Hydroxy-2-(di-n-propylamino)tetralin↗

Accelerated blood clearance of PEGylated liposomes upon repeated injections: effect of doxorubicin-encapsulation and high-dose first injection.

The "accelerated blood clearance (ABC) phenomenon", causing PEGylated liposomes to be cleared very rapidly from the circulation upon repeated injection, has been reported to occur in rodents and rhesus monkeys. This rapid clearance was reported to be caused by the binding of PEG-specific IgM, which was generated by the first dose of injected liposomes, to the second dose of liposomes and the subsequent activation of complement, serving in turn as an opsonin. Although there are several PEGylated liposomal formulations, such as Doxil/Caelyx loaded with doxorubicin (DXR), in clinical use, the rapid clearance phenomenon has never been reported for such formulations. In the present article, we report that a first injection of PEGylated liposomes containing encapsulated DXR failed to induce the ABC phenomenon. Likewise, no rapid clearance of the test dose was observed when the first dose of "empty" PEGylated liposomes (without DXR) exceeded 5 micromol phospholipids/kg. By contrast, "empty" PEGylated liposomes at a low dose (1 micromol phospholipids/kg) induced the phenomenon as before. Western blot analysis revealed abundant binding of IgM to PEGylated liposomes when these were incubated in serum from rats that had received "empty" PEGylated liposomes. Substantially less binding of IgM was found when the liposomes were incubated in serum from rats treated with DXR-loaded PEGylated liposomes. For both the empty and the DXR-containing liposomes the amounts of IgM binding to the liposomes decreased with an increasing dose of injected liposomes. Serum obtained from rats following injection of empty PEGylated liposomes caused complement activation by addition of PEGylated liposomes in an inversely dose-dependent manner: the lower the dose, the higher the complement activation. By contrast, no complement activation was detected with serum from rats that had been treated with DXR-loaded PEGylated liposomes. These findings suggest that encapsulation of DXR as well as a relatively high lipid dose abrogate the immune response against PEGylated liposomes which is observed with the same liposomes but without DXR and at low doses. Our observations may thus have important implications for the development, evaluation and therapeutic use of liposomal cytotoxic drug formulations requiring multiple injection schemes.

Animals↗

Peribulbar corticosteroid injection: vitreal and serum concentrations after dexamethasone disodium phosphate injection.

PURPOSE: To study the dexamethasone level reached in human vitreous after a peribulbar injection of 5 mg of dexamethasone disodium phosphate and to assess its systemic uptake. METHODS: In a prospective study, 61 eyes of 61 patients scheduled for vitrectomy received a single peribulbar injection of 5 mg of dexamethasone disodium phosphate at varied intervals before surgery. At the start of vitrectomy, an undiluted vitreous sample was taken. In 22 patients, multiple serum samples were collected. Dexamethasone concentrations were measured by radioimmunoassay. The physiologic cortisol concentration was determined in the vitreous of 12 eyes of 12 patients who did not receive dexamethasone. RESULTS: An average dexamethasone peak concentration of approximately 13 ng/ml was reached in vitreous 6 to 7 hours after peribulbar injection. In serum the average peak concentration was approximately 60 ng/ml 20 to 30 minutes after peribulbar injection. The average physiologic cortisol concentration in vitreous was 5.1 ng/ml. CONCLUSIONS: After a peribulbar injection of 5 mg of dexamethasone disodium phosphate, an average intravitreal dexamethasone concentration is reached with a 75 times greater anti-inflammatory potency than physiologically present cortisol. Dexamethasone concentration in serum, however, is several times higher. Peribulbar injection is not just a local treatment but results in serum levels comparable to those achieved by a high oral dose.

Adult↗

Delayed first injection of the once-a-month injectable contraceptive containing 25 mg medroxyprogesterone acetate and 5 mg estradiol-cypionate: effects on cervical mucus.

The objectives of this study were to assess whether women who were administered the first injection of the once-a-month contraceptive containing estradiol cypionate and 25 mg depot-medroxyprogesterone acetate (MPA+E(2)C) on Day 7 of their menstrual cycle (delayed injection) exhibit the same degree of cervical mucus changes as women who receive it on Day 5 of their menstrual cycle. This was a multicenter, randomized, controlled clinical trial. A total of 158 women, aged between 18 and 38 years (inclusive), who, were willing to use MPA+E(2)C as their contraceptive method participated in the trial. Participants received a MPA+E(2)C injection on Day 5 (control group, n = 41) or Day 7 (delayed-injection group, n = 117) of their menstrual cycle. Participants who received MPA+E(2)C on Day 5 of their menstrual cycle (control group) exhibited fair or poor mucus quality and poor sperm penetration. Of those women who received MPA+E(2)C on Day 7 of their menstrual cycle (delayed-injection group), 3 (3%) showed good mucus or good sperm penetration at some time point during follow-up. It is possible to conclude that the first injection of MPA+E(2)C given on Day 7 of a menstrual cycle does not provide the same degree of inhibition of mucus quality and sperm penetration as that observed if it is administered on Day 5. However, the theoretical risk of pregnancy after receiving MPA+E(2)C on Day 7 would be expected to be low.

Adult↗