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PubMed1984

Long-term reversible contraception with levonorgestrel-releasing Silastic rods.

Subcutaneously placed Silastic capsules containing levonorgestrel are effective for 5 years and have a higher continuation rate than other methods of reversible contraception. Six 3 cm capsules are required to achieve satisfactory circulating levels of levonorgestrel. Two 4 cm covered Silastic rods containing levonorgestrel, which are easier to manufacture, insert, and remove than the capsules, produce similar in vitro release rates. This study compared clinical and metabolic effects as well as bleeding patterns in 23 women using either six capsules (n = 11) or two covered rods (n = 12). Serum levels of levonorgestrel, lipids, and lipoproteins as well as frequency of elevated progesterone levels were compared in serum samples obtained before treatment and 1, 6, 12, 18, and 24 months after insertion with the two systems. While bleeding patterns were similar for users of the two systems, rod users had slightly higher serum levels of levonorgestrel and a lower incidence of cycles with elevated progesterone levels. Therefore, rods could replace capsules as a long-term, reversible contraceptive method.

Adolescent↗
PubMed1981

Intracervical release of levonorgestrel for contraception.

Twenty-one women used a levonorgestrel-releasing intracervical contraceptive device, which was designed to release 20 microgram/ay. The devices were inserted after cessation of menstrual bleeding. Patterns of bleeding and clinical performance wer evaluated and plasma concentrations of levonorgestrel, estradiol and progesterone in selected subjects were measured by radioimmunoassay. The results of the initial 90-day treatment are presented. Levonorgestrel was detected in peripheral plasma by 30 minutes after insertion of the device. Considerable variation of plasma levonorgestrel concentrations was observed between subjects, but within each subject, the plasma level of levonorgestrel was very stable with time. Of 24 cycles monitored by blood sampling, 19 were ovulatory. One subject did not ovulate at all. During the first 30-day period of treatment, frequent intermenstrual bleeding or spotting periods occurred. Two spontaneous expulsions occurred 9 and 22 days after insertion. Both of these subjects were nulligravidas. Side-effects were few and no pregnancies occurred during the study period.

Adult↗
PubMed1981

Plasma levels of levonorgestrel in women during longterm use of norplant.

Levonorgestrel plasma levels were determined by a specific radioimmunoassay in a group of 110 women at various intervals between 1 and 60 months following implantation of six silastic capsules containing levonorgestrel (Norplant). The implants were placed subdermally in the volar aspect of the forearm. Blood samples were taken twice a week for six consecutive weeks in each subject. Blood drawn from the antecubital vein ipsilateral to the implant site contained two to three times more levonorgestrel than contralateral samples. Average systemic plasma levels represented by contralateral samples ranged from 0.35 +/- 0.03 to 0.29 +/- 0.02 ng/ml (Mean +/- S.E.) in the first and fifth year, respectively. The difference between these values is statistically significant at the 5% level. The results of the regression analysis of individual levels suggest that the decline observed throughout the first five years is mainly due to an early decrease taking place in the first two years. When the sampling period was repeated in the same subjects two or three times 10 to 24 months apart, no significant difference was found. A significant negative correlation was found between plasma levonorgestrel levels and body weight and body surface. The data indicate that the contraceptive efficacy of Norplant during the first five years of use is associated with sustained release of levonorgestrel and is in keeping with the estimated life span of Norplant of seven years.

Female↗
PubMed2006

Pharmacokinetics of single-dose levonorgestrel in adolescents.

PURPOSE: The purpose of this study is to compare the pharmacokinetics of levonorgestrel, a drug used for emergency contraception between female adolescents and adults. METHODS: Twenty-two female subjects, aged 13-16 years, received a single 0.75-mg dose of the drug. Serial blood samples were collected for 72 h and used to measure plasma levonorgestrel concentrations. Previously published data from 16 adults, aged 18-45 years, served as comparison. RESULTS: There was a statistically significant higher total plasma clearance divided by the bioavailability (CL/F) of levonorgestrel in adolescents compared to adults, resulting in lower maximum and average total plasma concentrations. There was a trend for a larger volume of distribution divided by bioavailability (V/F), but there was no significant difference in the half-life of levonorgestrel in adolescents relative to adults (p=.098). CONCLUSION: The differences between adolescents and adults are unlikely to be clinically significant because specific changes in total concentrations suggest that unbound concentrations are probably not affected. Furthermore, empirically high doses of levonorgestrel are given for emergency contraception.

Adolescent↗
PubMed2004

Selective and sensitive liquid chromatography-tandem mass spectrometry method for the determination of levonorgestrel in human plasma.

A selective, sensitive and rapid liquid chromatography-tandem mass spectrometry method for the determination of levonorgestrel in plasma was developed. An Applied Biosystems API 3000 triple quadrupole mass spectrometer set to multiple reaction monitoring (MRM) mode, using atmospheric pressure photospray ionisation (APPI) in the positive mode. Using 17-alpha-methyltestosterone as internal standard (IS), liquid-liquid extraction was followed by reversed phase liquid chromatography using a phenyl-hexyl column and tandem mass spectrometric detection. The mean recovery for levonorgestrel and 17-alpha-methyltestosterone was 99.5 and 62.9%, respectively. The method was validated from 0.265 to 130 ng levonorgestrel/ml plasma with the lower limit of quantification (LLOQ) set at 0.265 ng/ml. This assay method makes use of the increased sensitivity and selectivity of tandem mass spectrometric (MS/MS) detection, allowing for a rapid (extraction and chromatography) and selective method for the determination of levonorgestrel in human plasma. The assay method was used in a pharmacokinetic study to quantify levonorgestrel in human plasma samples generated after administrating a single oral dose of 1.5 mg levonorgestrel to healthy female volunteers for up to five half lives. The total chromatographic runtime of this method was 5.0 min per sample, allowing for analysis of a large number of samples per batch.

Calibration↗
PubMed2000

Effect of local epididymal levonorgestrel on the fertilizing ability of male rat, a model for post-testicular contraception.

A thin levonorgestrel-silicone layer was applied on the capsule of the cauda epididymis of male rats to study a model for post-testicular male contraception. The effect of different levonorgestrel doses on the fertility of males was tested with fertile females. The time-dependent influence of a standard dose of levonorgestrel on serum LH and on testicular histology was estimated. Among the males tested, there was a group of animals where successful contraception with local application of levonorgestrel-silicone membrane was obtained. Sexual behavior was normal and the spermatogenesis was functioning, but the sperm were infertile. Although further research is needed to estimate adequate dose and strength of levonorgestrel in silicone matrix, this study shows that post-testicular contraception is possible to achieve.

Animals↗
PubMed2001

The effects of two progestogen-only pills containing either desogestrel (75 microg/day) or levonorgestrel (30 microg/day) on lipid metabolism.

The effects of two progestogen-only pills (POPs) containing either desogestrel (75 microg/day) or levonorgestrel (30 microg/day) on lipid metabolism were compared in a double-blind, randomized study in Sweden and Finland. Eighty-one healthy female volunteers received either desogestrel 75 microg/day or levonorgestrel 30 microg/day for seven treatment periods of 28 days. The following lipid parameters were measured at screening and at treatment Periods 3 and 7: total cholesterol, total triglycerides, HDL-cholesterol, HDL(2)-cholesterol, HDL(3)-cholesterol, LDL-cholesterol, apolipoprotein A-I, apolipoprotein A-II, apolipoprotein B, lipoprotein (a), and the carrier proteins sex hormone-binding globulin (SHBG) and cortisol-binding globulin. Overall, both study medications had similar, minimal effects on lipid metabolism. To summarize, compared with pre-treatment, no changes were observed for LDL-cholesterol and its protein fraction apolipoprotein B. The concentrations of total cholesterol and triglycerides decreased marginally. Decreasing trends were also seen for lipoprotein (a), HDL-cholesterol and its subfractions, HDL(2)-cholesterol and HDL(3)-cholesterol, and the apolipoproteins, apolipoprotein A-I and apolipoprotein A-II. The results indicated no significant differences between the groups in any of the parameters, with the exception of a smaller decrease in HDL(3)-cholesterol at treatment Period 7 for the desogestrel-containing POP compared with the levonorgestrel-containing POP and a significant difference between the two treatments for lipoprotein (a) at Period 3. The serum concentration of the carrier protein SHBG was found to be slightly higher in the desogestrel group, which may be a manifestation of the higher androgenicity of levonorgestrel compared with desogestrel. It can be concluded that the POP containing 75 microg desogestrel has a negligible effect on lipid metabolism. Despite the higher progestogen dose, the effect of this new POP is similar to that of a traditional POP containing 30 microg levonorgestrel.

Adolescent↗
PubMed1999

"Pop-out" method of levonorgestrel implant removal.

The "pop-out" technique is a method of levonorgestrel implant removal that uses digital pressure to direct implants through a small skin incision. This technique was developed, theoretically, to cause less bruising and patient discomfort by avoiding the use of instruments. The pop-out technique is the primary method used for levonorgestrel implant removal in the Magee-Womens Hospital resident clinic. We performed a retrospective analysis of levonorgestrel implant removals performed between July 1, 1995, and December 31, 1998. Of the 168 removals included in this analysis, 38 were performed by one of two attending physicians, and 130 were performed by the residents with attending supervision. The average time for removal was 12 +/- 5 min (range 2.25-27 min) when the "pop-out" method could be used to remove all six implants, and 14 +/- 7 min (range 2.25-59 min) for all removals. The removal time for residents was inversely proportional to the anticipated level of difficulty of the removal and to the number of previous removals performed. The removal time was significantly faster when residents were supervised by one of the attending physicians as compared with the other attending physician. Only 0.7% (7/1,008) of levonorgestrel implants were fragmented during removal. This review shows that the "pop-out" method is a reasonable alternative to other proposed methods of primary implant removal. The difference in the level of expertise of the attending physician may significantly influence removal time when training clinicians in levonorgestrel implant removal.

Adolescent↗
PubMed2003

Expression of matrix metalloproteinase-26 and tissue inhibitor of matrix metalloproteinase-3 and -4 in endometrium throughout the normal menstrual cycle and alteration in users of levonorgestrel implants who experience irregular uterine bleeding.

OBJECTIVE: To determine the expression of matrix metalloproteinase (MMP-26) and tissue inhibitor of MMP (TIMP) in the endometrium of women with normal menstrual cycles compared with users of levonorgestrel implants. DESIGN: Prospective observational study. SETTING: Academic research center. PATIENT(S): Fifty patients with normal menstrual cycles who requested permanent surgical sterilization (tubal ligation) and 35 users of levonorgestrel implants. INTERVENTION(S): Endometrial biopsy. MAIN OUTCOME MEASURE(S): Expression of MMP-26, TIMP-3, and TIMP-4 by immunohistochemistry and semiquantitative analysis of staining intensity by using the H score. RESULT(S): Endometrium from women with a normal menstrual cycle and users of levonorgestrel implants expresses MMP-26, TIMP-3, and TIMP-4. These substances are present in various types of endometrial cells; expression is strongest in surface and glandular epithelial cells, followed by vascular endothelial and endometrial stromal cells. Inflammatory and immune-related cells also stained strongly for MMP-26 and TIMPs. Semiquantitative analysis of the staining intensity of endometrial epithelial and stromal cells indicated that expression of MMP-26, TIMP-3, and TIMP-4 peaks during the early to mid-luteal phase. Expression of MMP-26 is elevated in users of levonorgestrel implants who experienced irregular uterine bleeding. CONCLUSION(S): Endometrial expression of MMP-26 and TIMP-4 is present throughout the menstrual cycle and is elevated during the early to mid-luteal phase in normally cycling women. Further elevations in MMP-26 are seen in users of levonorgestrel implants who experience irregular uterine bleeding. These substances thus seem to play a role in hormonal regulation and endometrial tissue remodeling.

Adolescent↗
PubMed1981

Intrauterine contraception with levonorgestrel: a comparative randomised clinical performance study.

Two levonorgestrel-releasing intrauterine devices (IUD) with different release rates of levonorgestrel and a 'Nova-T' copper-releasing device were compared in a randomised clinical performance study. 327 women had a levonorgestrel IUD and 156 women a nova-T device inserted postmenstrually. No statistically significant differences in the reasons for termination between the three devices were found in 12 months. The continuation rates for the two levonorgestrel IUDs were 84.1 and 81.4 and for the nova-T device 87.5. Duration of menstrual bleeding and spotting was highly significantly shorter with the levonorgestrel IUDs than with the nova-T device. There were no infections.

Adolescent↗
PubMed2004

A randomized trial to compare 24 h versus 12 h double dose regimen of levonorgestrel for emergency contraception.

BACKGROUND: Levonorgestrel (0.75 mg given for two doses 12 h apart) has been proven to be an effective regimen for emergency contraception when the first dose is given within 72 h of unprotected coitus. However, the dosing interval is inconvenient for those taking the first dose in the afternoon. We conducted a randomized study to evaluate two levonorgestrel dosing regimens for emergency contraception. Two doses of levonorgestrel 0.75 mg were administered with the first dose given up to 120 h after unprotected intercourse. The second dose was given 12 h later in the first regimen and 24 h later in the second regimen. METHODS: We conducted a double-blind, randomized trial between 1997 and 2003 at five centres in China. A total of 2071 women requesting emergency contraception within 120 h of unprotected intercourse were recruited. They were randomized to receive two doses of 0.75 mg of levonorgestrel, given either 24 h apart or 12 h apart. RESULTS: Outcome was unknown for 53 women (24 in the 24 h group and 29 in the 12 h group). Among the remaining 2018 women, the crude pregnancy rate was 1.9% in the 24 h group [95% confidence interval (CI) 1.17-2.94] and 2.0% in the 12 h group (95% CI 1.19-2.99). The proportion of pregnancies prevented was estimated to be 72% in the 24 h group and 75% in the 12 h group. Side-effects were mild in both groups. The efficacy of the 12 h regimen declined significantly when there were further acts of intercourse after treatment (5.0 versus 1.0%, P<0.01). This was not observed in the 24 h group. CONCLUSIONS: Two doses of 0.75 mg levonorgestrel given either 24 or 12 h apart are effective for emergency contraception up to 120 h after unprotected intercourse. Further research to investigative more effective methods of emergency contraception is warranted.

Adult↗
PubMed1996

Ethinyl oestradiol plus dl-norgestrel or levonorgestrel in the Yuzpe method for post-coital contraception: results of an observational study.

This observational study compares the efficacy and incidence of side-effects between dl-norgestrel (2 mg) and levonorgestrel (1 mg) associated with ethinyl oestradiol (200 micrograms) given in two doses 12 h apart for emergency post-coital contraception. A total of 117 consecutive women were given dl-norgestrel in combination with the oestrogen (dl-norgestrel group) while 423 consecutive subjects received the combination ethinyl oestradiol/levonorgestrel (levonorgestrel group). Overall, four (0.8%) pregnancies occurred in the 540 treated women, one (0.9%) in the dl-norgestrel group and three (0.7%) in the levonorgestrel group. In addition to this similar high contraceptive efficacy between both study groups, women in the levonorgestrel group had a significantly lower incidence of side-effects (23.5%) and better timing of the next menstruation after treatment (75% had bleeding on time) than those in the dl-norgestrel group (corresponding figures were 50.5 and 62.6% respectively). It is concluded that levonorgestrel should be used in preference to dl-norgestrel for post-coital contraception in the Yuzpe regimen.

Adolescent↗
PubMed2004

Long-term treatment of menorrhagia with levonorgestrel intrauterine system versus endometrial resection.

OBJECTIVE: The purpose of this study was to compare the long-term efficacy of the levonorgestrel intrauterine system and transcervical resection of the endometrium in the treatment of menorrhagia. METHODS: This study was an open, randomized 3-year trial. Patients with menorrhagia were assigned randomly to either the levonorgestrel intrauterine system (n = 30) or endometrial resection (n = 29). Pictorial blood loss assessment charts were used to measure menstrual blood loss. A pictorial blood-loss assessment chart score exceeding 75 (representing menstrual blood loss >/=60 mL) was used to diagnosis the patient as having menorrhagia. Discontinuations and cases requiring repeat operations were evaluated. RESULTS: Pictorial blood loss scores decreased from a baseline median of 261.5 (range, 60-1503) to 7 (range, 0-101; P < .001) for the levonorgestrel intrauterine system and from 311 (range, 81-2506) to 4 (range, 0-182; P < .001) for transcervical resection of the endometrium. Nineteen women of 30 using the levonorgestrel intrauterine system completed the 3-year follow-up compared with 22 of 29 for transcervical resection of the endometrium. CONCLUSION: Both treatments efficiently reduced menstrual bleeding. The high continuation rate suggests that the levonorgestrel intrauterine system is comparable with transcervical resection of the endometrium.

Adult↗
PubMed1998

Open randomised study of use of levonorgestrel releasing intrauterine system as alternative to hysterectomy.

OBJECTIVES: To assess whether the levonorgestrel intrauterine system could provide a conservative alternative to hysterectomy in the treatment of excessive uterine bleeding. DESIGN: Open randomised multicentre study with two parallel groups: a levonorgestrel intrauterine system group and a control group. SETTING: Gynaecology departments of three hospitals in Finland. SUBJECTS: Fifty six women aged 33-49 years scheduled to undergo hysterectomy for treatment of excessive uterine bleeding. INTERVENTIONS: Women were randomised either to continue with their current medical treatment or to have a levonorgestrel intrauterine system inserted. MAIN OUTCOME MEASURE: Proportion of women cancelling their decision to undergo hysterectomy. RESULTS: At 6 months, 64.3% (95% confidence interval 44.1 to 81.4%) of the women in the levonorgestrel intrauterine system group and 14.3% (4.0 to 32.7%) in the control group had cancelled their decision to undergo hysterectomy (P < 0.001). CONCLUSIONS: The use of the levonorgestrel intrauterine system is a good conservative alternative to hysterectomy in the treatment of menorrhagia and should be considered before hysterectomy or other invasive treatments.

Adult↗
PubMed1987

Efficacy of low-dose oral contraceptives containing levonorgestrel, gestoden and cyproterone acetate.

The efficacy of low-dose oral contraceptives containing 30 micrograms or 35 micrograms ethinyl estradiol in combination with Levonorgestrel, gestoden (delta 15-Levonorgestrel) and cyproterone acetate was studied. Borderline doses for inhibition of ovulation were found to be approximately 50 micrograms for Levonorgestrel, 40 micrograms for gestoden and 1 mg for cyproterone acetate. These results were derived from the assay of luteinizing hormone, follicle-stimulating hormone, 17 beta-estradiol and progesterone serum levels during the daily treatment of a total of 47 female volunteers from day 5 through day 25 of their cycles. A combination of 30 micrograms ethinyl estradiol plus 75 micrograms Levonorgestrel or 75 micrograms gestoden resulted in complete inhibition of ovulation in each of the 20 subjects studied. Monitoring of hormone serum levels in 6 female volunteers with normal cycles during the administration of 35 micrograms ethinyl estradiol plus 2 mg cyproterone acetate showed inhibition of ovulation in all subjects studied during the first and third therapy cycle. One subject exhibited follicular maturation during the third treatment cycle as judged from the patterns of 17 beta-estradiol serum levels. Present data suggest that low-dose oral contraceptives containing Levonorgestrel, gestoden and cyproterone acetate are highly efficient in providing great contraceptive safety and do not support the previous notion that the kind of progestagen used is relevant for the degree of central inhibition.

Adolescent↗
PubMedDate not supplied

[Reproductive performance of female wistar rat, descendent of mothers treated with levonorgestrel during the lactation].

UNLABELLED: Levonorgestrel is one of the contraceptives used by women during lactation. Previous studies have shown that the administration of levonorgestrel to lactating female rats has affected the offspring, causing puberty delay in males and alterations on uterus and oviduct weight. PURPOSE: To study the reproductive capacity of F1 females from rats treated with levonorgestrel. METHODS: Female Wistar rats were treated with levonorgestrel (0.030 mg/1 ml of distilled water) from day 7 to day 13 after birth (day 1 = birth). On day 90 F1 females were mated with fertile males and insemination was confirmed by the presence of spermatozoa in the vaginal smear (first day of pregnancy). Inseminated females were distributed in three groups of 20 animals each (10 F1 control and 10 F1 treated). The animals were killed on days 2, 4 and 5 after insemination by ether overdose inhalation and the ovaries, oviducts and uterine cornua were removed. The ovaries were weighed and the corpora lutea counted. Oviducts and corpora lutea were washed with saline solution and the pre-embryos were counted and examined in all segments. RESULTS: The ovaries weight, the number of corpora lutea, the number and development phase of the pre-embryos were similar in both groups. CONCLUSION: In the experimental model used, F1 females whose mothers were treated with levonorgestrel during lactation, did not show any alteration in their reproductive capacity.

Animals↗
PubMed1997

Three-year follow-up of the use of a levonorgestrel-releasing intrauterine system in hormone replacement therapy.

BACKGROUND: The efficacy of a levonorgestrel-releasing intrauterine system in opposing endometrial proliferation and in preventing bleeding was studied in peri- and postmenopausal women receiving estrogen replacement therapy. METHODS: This was an open, non-controlled follow-up study of the use of a levonorgestrel-releasing intrauterine system during continuous estrogen replacement therapy carried out by using oral, transdermal or subdermal estradiol. The efficacy of the progestin therapy was evaluated by transvaginal ultrasonography and by examination of endometrial biopsy samples taken 20 months (mean, range 17 - 22; first evaluation) and 34 months (mean, range 31 - 38 months; second evaluation) after insertion of the levonorgestrel-releasing intrauterine system, and by studying patterns of bleeding. Twenty-five women participated in the first evaluation, and 29 in the second. RESULTS: Seventy-six percent of the women were amenorrheic at the first evaluation, and 79% at the second evaluation. Others had spotting for 1-2 days monthly or less often. The mean time until amenorrhea was reached was 6 months (range 2-13 months) after insertion of the levonorgestrel-releasing intrauterine system. The median endometrial thickness assessed by ultrasound was 2 mm at both evaluations. No signs of proliferation were observed in any of the endometrial samples. CONCLUSIONS: Local progestin delivery via a levonorgestrel-releasing intrauterine system was effective in suppressing the endometrium and in eliminating bleeding in women receiving estrogen replacement therapy, and the intrauterine progestin therapy was also well accepted.

Aged↗
PubMed2001

The effects of two progrestogen-only pills containing either desogestrel (75 microgram/day) or levonorgestrel (30 microgram/day) on carbohydrate metabolism and adrenal and thyroid function.

OBJECTIVE: To compare the effects of two progestogen-only pills, containing either desogestrel or levonorgestrel, on carbohydrate metabolism, and adrenal and thyroid function. METHODS: In a double-blind, randomized, multicenter study in Finland, 84 healthy female volunteers received either desogestrel 75 microg/day or levonorgestrel 30 microg/day for seven treatment periods of 28 days. The following laboratory parameters were measured at screening, and at treatment periods 3 and 7: carbohydrate metabolism (glucose, insulin, glycosylated hemoglobin (HbA1C)), adrenal function (total cortisol, cortisol binding globulin (CBG), dehydroepiandrosterone sulfate (DHEAS)), thyroid function (thyroid stimulating hormone, free thyroxine). RESULTS: Overall, the effect on carbohydrate metabolism was minimal with both study medications. There was a trend for higher glucose and insulin values for the levonorgestrel group at both treatment periods 3 and 7. None of the changes were thought to be clinically relevant. Both preparations had similar small effects on HbA1C values, indicating that carbohydrate metabolism was not affected. No effects were found on thyroid function parameters or DHEAS in either treatment group; however, total cortisol and CBG were slightly higher with desogestrel than with levonorgestrel. These changes were not considered to be clinically relevant. Both treatments were well tolerated. CONCLUSIONS: The effects of both progestogen-only pills on carbohydrate metabolism were minimal and considered to be clinically insignificant. With regard to adrenal and thyroid function, the effects of desogestrel were not significantly different from those of levonorgestrel.

Adolescent↗