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Effects of progesterone intravaginal devices on synchronization of estrus in postpartum dairy cows.

Effects of two intravaginal treatments of progesterone on the synchronization of behavioral estrus were compared in three groups of lactating dairy cows at 7 to 8 wk postpartum. Group 1 had progesterone-releasing intravaginal devices with attached estradiol benzoate capsules inserted for 12 d. Groups 2 and 3 had controlled internal drug release devices, containing progesterone alone, inserted for 9 or 12 d. Behavioral estrus was detected as early as 24, 32, and 36 h after removal of the devices in groups 1, 2, and 3, respectively. Estrus was better synchronized and the proportion of cows showing estrus after device removal was greater in group 1 than in groups 2 and 3. After removal of devices, mean milk progesterone of all cows that did not show estrus was higher than that of cows that showed estrus. In groups 1, 2, and 3, 1 of 7, 7 of 12, and 4 of 12 cows not showing estrus had high milk progesterone after removal of the devices, indicating the presence of functional corpora lutea. In cows not displaying estrus milk progesterone concentrations decreased, indicating these cows were cyclic, although behavioral estrus was absent.

Administration, Intravaginal↗

Preinduction cervical ripening: a randomized prospective comparison of the efficacy and safety of intravaginal and intracervical prostaglandin E2 gel.

OBJECTIVE: The purpose of this study was to compare the effectiveness and safety of vaginally administered 5 mg prostaglandin E2 gel prepared in our hospital pharmacy with a commercially available 0.5 mg intracervical prostaglandin E2 gel. STUDY DESIGN: Eighty-three patients undergoing labor induction were randomly assigned to one of two groups for cervical ripening. Either a preparation of 5 mg of prostaglandin E2 was placed vaginally or a commercially available 0.5 mg of prostaglandin E2 was placed intracervically. A maximum of three doses at 6-hour intervals was administered before oxytocin was begun. RESULTS: Among the 83 patients evaluated, 44 were given vaginal gel and 39 were given intracervical gel. No statistically significant differences were observed between the two treatment groups with respect to the incidence of spontaneous versus induced labor, need for oxytocin augmentation, gel-to-induction interval, Bishop score change, maximum oxytocin dose, maximum dilatation rate, length of labor, cesarean section rate, fetal Apgar scores, fetal umbilical vein pH, or fetal umbilical artery pH. CONCLUSIONS: The two prostaglandin E2 formulations appear equivalent in efficacy and safety. Constraints placed on intracervical prostaglandin E2 gel make the vaginal preparation a desirable choice.

Administration, Intravaginal↗

Luteal function and estrus in peripubertal beef heifers treated with an intravaginal progesterone releasing device with or without a subsequent injection of estradiol.

The objectives of this experiment were to determine if treatment of beef heifers with progesterone (P4) using an intravaginal device alone or in combination with estradiol benzoate (EB) would induce estrus and cause development of corpora lutea (CL) with a typical life span. Peripubertal heifers (n = 311) were used when about 40% of the heifers had a functional CL. The heifers were assigned to receive one of the following treatments on Day 0: 1) a sham device for 7 d (C, n = 108); 2) an intravaginal device containing P4 for 7 d (P, n = 102); or 3) an intravaginal device containing P4 for 7 d plus an injection of 1 mg EB 24 to 30 h after device removal (PE, n = 101). Serum concentrations of P4 were determined on Days -7, 0, 8, 15 and 22. Weight and age of the heifers at the start of the trial averaged 292 +/- 45 kg and 365 +/- 38 d, respectively. A greater (P < 0.0001) proportion of the heifers from the PE than P group was in standing estrus (81 vs 37%) and formed normal CL (68 vs 44%) after device removal. Of the heifers exhibiting estrus, a greater (P < 0.05) proportion of PE (94%) than P (80%) heifers was active 1 to 3 d after implant removal. Short-term progesterone treatment increased the proportion of heifers in estrus and those forming normal CL, and adding EB to the progesterone treatment further enhanced these responses.

Administration, Intravaginal↗

Preclinical studies of alkylureas as anti-HIV-1 contraceptive.

The HIV-1 epidemic continues to spread at a rate of over 15, 000 new cases daily. HIV-1 transmission through heterosexual contact became the dominant risk for women globally. About half of the over 40 million HIV-1 infected individuals worldwide are now women. The lack of empowerment of women is the fundamental cause for the rampant spread of HIV-1 in women. Topical microbicides applied intravaginally offer an option for female-initiated HIV-1 prevention. There is an urgent need to develop microbicides with and without contraceptive qualities to also address socio-cultural settings where the woman's status is linked to fertility. A safe and efficacious anti-HIV-1 vaginal formulation is not yet available though a large number of candidates are in preclinical or clinical studies. Presently marketed topical microbicides are by and large toxic and damage the vaginal mucosa with frequent use. The microbicidal system of alkylureas evaluated here lends itself to contraceptive and non-contraceptive anti- HIV-1 formulations. Alkylureas are agents that irreversibly disrupt free and intracellular HIV-1, have a wide margin of safety and are spermicidal above their virucidal concentration without any mucosal toxicity. Butylurea, the lead compound is also effective against other sexually transmitted diseases (STDs) while sparing the normal vaginal flora. Alkylureas with longer alkyl chains still have to be explored and may have a greater selective microbicidality.

Administration, Intravaginal↗

Fate of the dominant follicle, embryonal survival, and pregnancy rates in dairy cattle treated with prostaglandin F2 alpha and progestins in the absence or presence of a functional corpus luteum.

Our objective was to examine the role of progestin type on serum concentrations of progesterone (p4) and estradiol-17 beta (E2), ovarian follicular dynamics, and fertility in cattle in the presence or absence of a corpus luteum (CL) in an estrus synchronization scheme using progestin and PGF2 alpha. In Exp. 1, 325 cows and heifers were given one injection of PGF2 alpha (d 0) and then assigned randomly within parity to five treatments: to receive a second PGF2 alpha injection 14 d later (control); to receive norgestomet (NORG) for 7 d beginning on d 8, with a second PGF2 alpha injection given either 1 d (NORG + no CL) or 6 d (NORG + CL) after insertion; or to receive a P4-releasing intravaginal device (PRID) in lieu of norgestomet at comparable times. Presence or absence of a CL was based on concentrations of serum P4 on d 14. Pregnancy rates after insemination were greater (P < .01) with luteal treatments than with nonluteal treatments. Embryonal survival between two stages of pregnancy was 87.6%. In Exp. 2, ovarian structures in 50 cows were examined daily using ultrasonography and the same five treatments. Diameter of the ovulatory follicle was greater (P < .05) with the nonluteal treatments (NORG and PRID + no CL) than with the control and luteal treatments (PRID and NORG + CL). Replacement of the dominant follicle during progestin treatment was altered by treatment (luteal status) and stage of the estrous cycle. Fertility was not enhanced by exogenous progestins when a CL was present. In the absence of a CL, progestin (P4 less than NORG at the doses used) reduced fertility by increasing E2 and the diameter of the ovulatory follicle and decreasing turnover of dominant follicles.

Administration, Intravaginal↗

Systemic and mucosal immunity is elicited after both intramuscular and intravaginal delivery of human immunodeficiency virus type 1 DNA plasmid vaccines to pregnant chimpanzees.

DNA vaccines encoding human immunodeficiency virus type 1 (HIV-1) env/rev and gag/pol were delivered intravaginally (IVAG) and intramuscularly (IM) to 2 pregnant chimpanzees. Vaccination was well tolerated and each chimpanzee developed antibodies (up to 1 year later) to both vaccines. Placental transfer of anti-Env and anti-Gag IgG was demonstrated in both maternal/infant pairs. Specific IgG was also demonstrated in saliva, vaginal, and rectal washes after IVAG immunization. Predominantly anti-HIV-1 IgA was detected in the milk of both mothers after both IM and IVAG immunization. Cellular responses included Gag-specific proliferation of lymphocytes and cytotoxic T lymphocytes against both antigens. These data suggest a strategy for induction of mucosal and systemic responses after both IM and IVAG delivery of DNA vaccines in a primate model and could ultimately be useful in lowering maternal-to-fetal transmission of HIV-1, perinatally and through breastfeeding.

AIDS Vaccines↗

[Comparison of misoprostol and ricinus oil meal for cervical ripening and labor induction].

OBJECTIVE: To compare the safety and efficacy of intravaginal prostaglandin E1, misoprostol with ricinus oil meal for labor induction. METHODS: Sixty patients with an indication for induction of labor were randomly assigned to two groups (30 cases each) induction with misoprotol, 50 micrograms intra-vaginally every 3 hours until active labor, or with that ricinus oil meal was taken. RESULTS: The time from start of induction to vaginal delivery was significantly shorter in the misoprostol group (12.2 vs 18.1, P < 0.05), and fewer patients in the misoprostol group required oxytocin augmentation (10.0% vs 40.0%, P < 0.05). The mean change in the Bishop score was significantly higher in those receiving misoprostol (5.5 vs 3.1, P < 0.05). Uterine tachysystole occurred more frequently in patients in the misoprostol group (16.7%) than in the ricinus oil meal group (3.0%). No significant differences were noted in the mode of delivery and patients of successful labor induction. CONCLUSIONS: Vaginally administered misoprostol is an effective agent for the cervical ripening and induction of labor.

Abortifacient Agents, Nonsteroidal↗

Mifepristone followed on the same day by vaginal misoprostol for early abortion.

We performed a pilot study to examine the clinical efficacy of mifepristone 200 mg followed on the same day by misoprostol 800 microg vaginally in women with pregnancies up to 49 days gestation. Forty women received mifepristone 200 mg after which they self-inserted misoprostol intravaginally 6 to 8 h later at home. Participants returned for an evaluation, including transvaginal ultrasonography, 24 +/- 1 h after using the misoprostol. Participants who had not aborted received a second dose of misoprostol to administer 48 h after the mifepristone. All participants returned approximately 2 weeks after receiving mifepristone. At 24 h after receiving misoprostol, 37/40 (92%, 95% CI 81-98%) had ultrasonographic evidence of complete abortion. By follow-up 2 weeks after the mifepristone, 40/40 (100%, 95% CI 92-100%) women were felt to have complete abortions. One subject subsequently had a suction aspiration for an incomplete abortion on study Day 44. Nausea, vomiting, diarrhea, and warmth/chills occurred in 38%, 13%, 13%, and 60%, respectively. This pilot study suggests that mifepristone 200 mg, followed on the same day by misoprostol 800 microg vaginally, effects abortion at rates comparable to regimens using the standard time interval of 48 h between medications.

Abortifacient Agents, Nonsteroidal↗

A comparison of intravaginal misoprostol and intracervical prostaglandin E2 gel for ripening of unfavorable cervix and labor induction.

OBJECTIVE: To study the effectiveness of single application of intravaginal misoprostol versus intracervical prostaglandin E2 gel for ripening the unfavorable cervix and labor induction. METHOD: One hundred and ten patients with indications for induction of labor with unfavorable cervices were randomized to receive either 100 microgram tablets of misoprostol placed in the posterior vaginal fornix or prostaglandin E2 1.5 mg in gel placed into the endocervix. Those, who were not in active labor after 24 hours, had labor induced with amniotomy and oxytocin. RESULTS: Among 110 patients recruited, 60 received misoprostol and 50 received prostaglandin E2 gel. The average interval from start of induction to vaginal delivery was 19.14 +/- 10.64 hours in misoprostol group and 21.37 +/- 13.09 hours in the prostaglandin E2 group (p = 0.33). Five patients (8%) in the misoprostol group had induction of labor after 24 hours of the treatment compared with 13 patients (26%) in the PGE2 group. The difference was significant (p = 0.03). Oxytocin augmentation was 35% in the misoprostol group and 34% in the prostaglandin E2 group (p = 0.86). There were no significant differences between routes of delivery. Nineteen patients (31%) in misoprostol group and 16 patients (32%) in the PGE2 gel group had cesarean deliveries. There was one case (1.7%) of uterine hyperstimulation in the misoprostol group and none in the PGE2 gel group. There were no significant difference in Apgar scores < 7 at 1 and 5 minutes, or admission to the neonatal intensive care unit between the 2 groups. CONCLUSION: Vaginal misoprostol is an effective agent for cervical ripening and induction of labor. Complications associated with prostaglandin administration were not statistically different between the 2 groups, but hyperstimulation occurred more in misoprostol group.

Administration, Intravaginal↗

Comparison of intravaginal and two intracervical prostaglandin E2 gels in pre-induction of labour.

A randomized study was undertaken to compare the effect of vaginal (1 mg of dinoprostone/2.5 ml gel) and intracervical (0.5 mg of dinoprostone in 2.5 ml of two different vehicles) on induction of labor and perinatal outcome. Sixty women (n = 20/20/20) who presented with an unfavorable cervix and a specific indication for the induction of labor participated in the study. There were no significant differences between the groups with respect to maternal age, weight, parity, gestational length or Bishop scores before prostaglandin E2 preinduction. Labour was induced with prostaglandin gel alone in twenty-two patients and with oxytocin infusion on the following morning after gel application in seven patients; altogether the rate of successful induction was 48.3%. The rate of uterine hyperstimulation was 16.7% with most cases in the groups receiving intracervical prostaglandin E2. Neonatal asphyxia diagnosed with umbilical vein and artery blood gas analysis was seen in eleven neonates who were delivered by labor induced with prostaglandin gel alone (50%). Prostaglandin pre-induction decreases the need for Cesarean sections in complicated pregnancies, but because of the risk of uterine hyperstimulation and neonatal asphyxia prostaglandins should be used only with specific indications.

Administration, Intravaginal↗

Second trimester abortion using intravaginal misoprostol.

OBJECTIVE: To find the effective dose of intravaginal misoprostol to induce second trimester abortion. METHODS: Intravaginal misoprostol in 200-microg, 400-microg and 600-microg doses were applied at 12-h intervals in 150 consecutive pregnancies. RESULTS: The 48-h successful abortion rate was 70.6%, 82% and 96%, respectively, and these rates were unaffected by parity. The mean induction to abortion interval was 45.0 +/- 41.5, 33.4 +/- 34.9 and 22.3 +/- 14.3 h, respectively. The mean dose of misoprostol required to induce abortion was 416.7 microg, 772.8 microg and 1296 microg. The rate of nausea and vomiting was 3.9%, 12% and 20%. The diarrhea occurrence rate was 0%, 6% and 22% with temperature elevation 0%, 2% and 28%, respectively. The rate of incomplete abortion was 35.3%, 28% and 22%, respectively. CONCLUSION: The 600-microg dose is more effective as an abortifacient agent for second trimester abortion in terms of 48-h success rate and the rate of incomplete abortion but with more side effects. However, the side effects were mild and did not warrant any specific treatment.

Abortifacient Agents, Nonsteroidal↗

CD8+ T-cell-mediated cross-clade protection in the genital tract following intranasal immunization with inactivated human immunodeficiency virus antigen plus CpG oligodeoxynucleotides.

Human immunodeficiency virus (HIV) is a mucosally transmitted infection that rapidly targets and depletes CD4+ T cells in mucosal tissues and establishes a major reservoir for viral persistence in gut-associated lymphoid tissues. Therefore, vaccines designed to prevent HIV infections must induce potent and durable mucosal immune responses, especially in the genital tract. Here we investigated whether intranasal (i.n.) immunization with inactivated gp120-depleted HIV-1 antigen (Ag) plus CpG oligodeoxynucleotide (ODN) as an adjuvant induced local immune responses in the genital tract and cross-clade protection against intravaginal (IVAG) challenge. Lymphocytes isolated from the iliac lymph nodes (ILNs) and genital tracts of female mice i.n. immunized with HIV-1 Ag plus CpG showed significant HIV-specific proliferation and produced significantly higher levels of gamma interferon (IFN-gamma) and beta-chemokines than mice immunized with HIV-1 Ag alone or mixed with non-CpG ODN. CD8+ lymphocytes were dramatically increased in the genital tracts of mice immunized with HIV-1 Ag plus CpG, and protection following IVAG challenge with recombinant vaccinia viruses (rVVs) expressing HIV-1 gag was shown to be CD8 dependent. Finally, cross-clade protection was observed between clades A, C, and G but not B following IVAG challenge with rVVs expressing HIV-1 gag from different clades. These studies provide evidence that mucosal (i.n.) immunization induced strong local T-cell-mediated immune responses in the genital tract and cross-clade protection against IVAG challenge.

AIDS Vaccines↗

Bacterial vaginosis: diagnostic and pathogenetic findings during topical clindamycin therapy.

We examined subjective and objective correlates among 67 women with symptomatic bacterial vaginosis before and after treatment with intravaginal clindamycin or placebo. We found no preponderance of any sexual practices among these patients. Nine patients (13.4%) had had hysterectomy. Whereas odor and discharge were the most common symptoms, 30 patients (44.8%) also complained of vulvovaginal irritation. Symptoms correlated poorly with objective therapeutic outcome. On examination the diagnosis would have been missed in seven patients (10.4%) if the clinician relied on presence of an abnormal vaginal discharge to suggest bacterial vaginosis. Vaginal pH greater than 4.5 was found immediately after curative therapy in 59.6% of patients. Mobiluncus spp. morphotypes were 99.0% specific and 52.1% sensitive and proline aminopeptidase activity in vaginal fluid was 84.4% sensitive and 70.2% specific for diagnosis. Our Gram stain criteria yielded no false-negative results, 6.1% false-positive, and frequent indeterminate results after therapy. We found little evidence for sexual transmission of bacterial vaginosis. Recurrence after effective therapy was not predicted by vaginal pH elevation, positive or indeterminate Gram stain result, or positive proline aminopeptidase test.

Administration, Intravaginal↗

Use of fluorogestone acetate after breeding to reduce the effect of premature luteal regression in dairy goats when superovulation is induced with FSH.

The aim of the present study was to determine the effect of fluorogestone acetate (FGA) administered after mating, on embryo production in the dairy goat subjected to conventional superovulatory and embryo recovery protocols. Adult does, most of them of the French Alpine breed, were randomly assigned after a FSH-superovulatory estrus and fertile matings to a control group (n=20) or to a treated group (n=20) in which intravaginal sponges impregnated with FGA were inserted after mating and remove before embryo collection (day 6). Blood samples were collected every 12h from days 1 to 7 post-estrus and serum progesterone concentrations were determined. The FGA-group had a lesser percentage of does with normal corpora lutea (CL) and a greater percentage of animals with CL in regression or mixed (normal and in regression) when compared with the control group (13.3 and 64.7%, 53.3 and 23.5%, and 33.3 and 11.8%, respectively; P<0.05). Mean number of normal CL per doe was less and mean number of regressed CL greater in FGA as compared with the control group (4.2 compared with 10.7 and 8.5 compared with 3.6, respectively; P<0.05). There were no differences (P>0.05) in recovery rate, total number of CL, total recovered structures, oocytes and transferable and non-transferable embryos between groups. Serum progesterone concentrations from day 5 to 7 post-estrus were lower (P<0.05) in FGA as compared with the control group. Percentage of does with luteal failure on day 6 post-estrus was greater in FGA as compared with the control group (86.6 compared with 33.3%; P<0.01). When considering only does with luteal failure on day 6 post-estrus, mean total recovered structures, transferable embryos and percentage of does rendering > or =3 transferable embryos were greater in the FGA compared with the control group (6.3 and 1.3 structures, 4.5 and 1.2 embryos, 67 and 17%, respectively; P<0.05). In does not having luteal failure, FGA administration did not appear to affect embryo production or embryo survival. These results indicate that FGA administration after mating improves embryo recovery in dairy goats with luteal failure after superovulatory treatment. However, it also increases the incidence of luteal regression when administered early in the estrous cycle.

Administration, Intravaginal↗

Outpatient use of prostaglandin gel for ripening of the cervix and induction of labor.

This case series reports the experience in a family practice center with the outpatient use of prostaglandin E2 (PGE2) gel in patients with a medical or obstetric indication for induction. A retrospective medical record review of a 15-month period was completed for 45 women receiving intravaginal PGE2 gel for cervical ripening before the induction of labor. A change in Bishop score was seen following application of the first gel in 21 women (54%). Six women (13%) had labor onset 1 to 16 hours after the initial gel placement, and an additional 19 women (42%) had labor onset within 48 hours of the final gel placement. Twenty-one women (47%) gave birth without the use of oxytocin, and only 11 women (24%) required oxytocin induction of labor. No significant differences were seen in type of delivery, delivery complications, or newborn outcome between categories of labor onset (spontaneous, PGE2 gel, oxytocin). Two complications followed gel insertions, one case of uterine hyperstimulation and one case of a brief episode of fetal bradycardia. Both women were identified within the monitoring period and subsequently were delivered of healthy term infants. This case series demonstrates the usefulness and lack of adverse effects of outpatient PGE2 gel as an adjunct in labor induction.

Administration, Intravaginal↗

Supplemental norgestomet, progesterone, or melengestrol acetate increases pregnancy rates in suckled beef cows after timed inseminations.

In Exp. 1, 187 lactating beef cows were treated with injections of GnRH 7 d before and 48 h after prostaglandin F2alpha (PGF2alpha; Cosynch) or with Cosynch plus a 7-d treatment with an intravaginal progesterone (P4)-releasing insert (CIDR-B; Cosynch + CIDR). In Exp. 2, 183 lactating beef cows were treated with the Cosynch protocol or with Cosynch plus a 7-d treatment with norgestomet (Cosynch + NORG). In Exp. 1 and 2, blood samples for later P4 analyses were collected on d -17, -7 (first GnRH injection), 0 (PGF2alpha injection), and at timed artificial insemination (TAI; 48 h after PGF2alpha). In Exp. 3, 609 lactating beef cows were treated with the Cosynch + CIDR protocol or were fed 0.5 mg of melengestrol acetate (MGA) per day for 14 d before initiating the Cosynch protocol 12 d after the 14th d of MGA feeding (MGA + Cosynch). Blood samples were collected as in Exp. 1 and 2, plus additional samples on d -33 and -19 before PGF2alpha. In Exp. 4, 360 lactating beef cows were treated with a Cosynch + CIDR protocol, with TAI occurring at either 48 or 60 h after PGF2alpha, while receiving either GnRH or saline to form four treatments. Blood samples were collected as in Exp. 1 and 2. In Exp. 1, addition of P4 reduced the ability of the first GnRH injection to induce ovulation in anestrous cows with low P4 before PGF2alpha but improved (P = 0.06) pregnancy rates (61 vs 66%). In Exp. 2, the addition of NORG mimicked P4 by likewise increasing (P < 0.01) pregnancy rates (31 vs 51%) beyond those after Cosynch. In Exp. 3, the Cosynch + CIDR protocol increased (P < 0.001) pregnancy rates from 46 to 55% compared to the MGA + Cosynch protocol. In Exp. 4, administration of GnRH at TAI improved (P < 0.05) pregnancy outcomes (50 vs 42%), whereas timing of TAI had limited effects. We conclude that a progestin treatment concurrent with the Cosynch protocol improved pregnancy outcomes in all experiments, but pretreatment of cows with MGA was not as effective as the CIDR insert or NORG implants in this Cosynch-TAI model. Most of the improvement in pregnancy rates was associated with the increase in pregnancy rates of anestrous cows, regardless of whether ovulation was successfully induced in response to GnRH 7 d before PGF2alpha. Injection of GnRH at TAI following the Cosynch + CIDR protocol increased pregnancy rates in cycling cows with high P4 before the PGF2alpha injection and in anestrous cows with low P4 before PGF2alpha injection.

Administration, Intravaginal↗

Progesterone supplementation increases luteal phase endometrial thickness and oestradiol levels in in-vitro fertilization.

Luteal phase supplementation with natural progesterone appears to increase the pregnancy rate in in-vitro fertilization (IVF). The objective of this investigation was to examine the effect of intravaginal progesterone on endometrial thickness and hormonal parameters 7-9 days after embryo transfer. IVF patients receiving progesterone supplementation (Prog +, n = 64), who did not conceive, were compared to patients not receiving progesterone (Prog -, n = 23) because of failed fertilization. These two groups were also compared to 20 women (Preg) who conceived and to 16 women (control) in the mid-luteal phase of natural cycles. Endometrial thickness was greater (P < 0.01) in the Prog + (0.88 +/- 0.04 cm) and Preg (0.92 +/- 0.02 cm) groups compared to the Prog - (0.71 +/- 0.05 cm) and control (0.65 +/- 0.05 cm) groups. Mean luteal phase serum oestradiol levels were also higher (P < 0.05) in the Prog + (1118 +/- 112 pmol/l) and Preg (2267 +/- 757 pmol/l) groups than in the Prog - (574 +/- 70 pmol/l) and control (468 +/- 38 pmol/l) groups. These findings suggest that progesterone supplementation may affect pregnancy rates in IVF by increasing endometrial thickness, thereby enhancing receptivity for implantation. The mechanism through which this effect occurs is unclear but may involve serum oestradiol elevation.

Administration, Intravaginal↗

Subchronic vaginal toxicity studies of Alcide Allay gel and liquid in guinea pigs.

Alcide Allay, an antimicrobial preparation produced in gel and liquid forms, was evaluated for vaginal toxicity in guinea pigs. 1.0 g/kg Allay gel or placebo was administered intravaginally once per day over a 30 day period while 2.5 g/kg Allay liquid (containing either of two concentrations of sodium chlorite and lactic acid as active ingredients) or placebo was applied vaginally three times per day for 10 days. At the conclusion of the studies, hematology, blood and urine clinical chemistry tests and necropsies were performed. RBC, HGB, HCT, MCHC and direct bilirubin increased while CO2, SGPT and CPK decreased in blood after Allay liquid treatment. Creatinine, urea nitrogen and uric acid in urine were statistically reduced in the liquid groups. Hematology and clinical chemistry parameters were within the normal range of values reported in the literature for guinea pigs, indicating no clinical significance due to drug treatment. Significant differences in organ body/weight ratios were observed between controls and Allay gel and liquid groups. However, only the livers in the gel study and the vaginas in both studies were changed histologically.

Administration, Intravaginal↗