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PubMed1984

Comparative evaluation of contraceptive efficacy of norethisterone oenanthate (200 mg) injectable contraceptive given every two or three monthly. Indian Council of Medical Research Task Force on Hormonal Contraception.

A total of 2388 subjects, 1181 for 60 +/- 5-day and 1207 for 90 +/- 5-day treatment regimen with norethisterone oenanthate (NET OEN) 200 mg injection, were observed for 24 months, constituting 28,513 woman-months. This clinical trial represents the largest clinical trial undertaken on NET OEN. The observations indicated that NET OEN given at 60 +/- 5-day intervals provides adequate contraceptive protection. However, as compared to the published studies elsewhere, higher method failures were seen during the first six months of NET OEN usage, when all women were receiving the drug at 60 +/- 5-day intervals. The reasons for this discrepant observation in the present study cannot be explained. The higher method failures reported with 90 +/- 5-day regimen were mainly during the third month following the injection, suggesting reduced contraceptive efficacy of the drug during this period. Thin build women (body weight less than or equal to 40 kg) were at higher risk of involuntary pregnancy. Disrupted menstrual pattern was the major reason for discontinuation ranging between 42-43 per 100 users at the end of 24 months. Amongst these, amenorrhoea was the commonest reason for discontinuation. No change in blood pressure was observed during contraceptive usage. The majority of NET OEN users did not show any change in body weight. The overall continuation rates with NET OEN were lower than those observed in similar conditions with Cu-T 200 mm2 IUCD.

Adult↗
PubMed1993

[Cancer of the ovary and the hormonal context].

Screening for ovarian cancer can only be worthwhile if it is applied to a population at risk. Recent studies show that there is a significant lowering of the risk for cancer of the ovary after all contraceptive preparations containing oestrogens and progestogens have been used. The longer these preparations are used the greater the protection for the user and this protection continues for a long time after treatment has stopped. One finds, in truth, that if the ovary is put functionally at rest whether it is because ovulation has been stopped by pregnancy or by oral contraception or by a premature menopause, or late puberty, the ovaries are somewhat protected from cancer. On the other hand, women whose reproductive life is long without being interrupted as far as ovarian function is concerned, have a higher risk of developing cancer and, therefore, would be worthwhile screening. Furthermore, on the other hand the problems of stimulating the ovaries when treating for sterility must be considered in the relationship to the possibility of provoking cancer of the ovary. A better knowledge of the hormone status would make it easier to decide what cases should be screened for epithelial cancer of the ovary so that the prognosis can be less disastrous than it is.

Age Factors↗
PubMed2005

Hormonal contraception: noncontraceptive benefits and medical contraindications.

This article delineates the noncontraceptive benefits of hormonal contraception, including combined and progestin-only methods. Contraindications to the use of these hormonal methods also are discussed. Knowledge of the noncontraceptive benefits of birth control methods can increase compliance and continuation of use, with the ultimate goal of decreasing unplanned pregnancy.

Adolescent↗
PubMed1995

Gynecologic and obstetric aspects of Gaucher's disease: a survey of 53 patients.

OBJECTIVE: We report our experience on the gynecologic and obstetric features of 53 female patients with Gaucher's disease. STUDY DESIGN: Each patient was interviewed for a detailed medical history, and all underwent a complete physical examination and laboratory work-up. RESULTS: Delay of puberty onset was encountered in two thirds of the patients without subsequent infertility. Heavy menstrual bleeding was a major problem and was best treated with low-dose oral contraceptives. Of the 102 spontaneous pregnancies' 25 (24.5%) ended in spontaneous first-trimesters abortions; 72 continued beyond the twenty-second week. Nine patients (27.7%) were diagnosed as having Gaucher's disease during their first pregnancies. Aggravation of thrombocytopenia and anemia were prominent features, but antepartum blood transfusion was not required. Early postpartum hemorrhage and fever were increased after both cesarean and vaginal deliveries. Development of bone crisis in seven women during the third trimester and early postpartum periods recurred in subsequent pregnancies. Genotypes had not influenced the gynecologic or obstetric manifestations. CONCLUSIONS: Gynecologic and obstetric complications play a significant role in this patient population, representing an additional burden to female patients with Gaucher's disease.

Abortion, Spontaneous↗
PubMed1987

A clinical trial of Neo Sampoon vaginal tablets and Emko foam in Alexandria, Egypt.

Results are reported for a comparative 12-month study of Neo Sampoon foaming vaginal tablets containing 60 mg of the spermicide, menfegol, and Emko vaginal foam containing an 8.0% concentration of the spermicide, nonoxynol-9. Conducted in cooperation with the Family Planning Association in Alexandria, Egypt, the trial included 349 women who were randomly allocated to use one of the two contraceptive products. The twelve-month cumulative life-table rate for accidental pregnancy (per 100 women) was 2.8 for Neo Sampoon tablet users and 2.1 for Emko foam users. The 12-month continuation rates were 77.6 and 77.2 per 100 women for the tablet and foam groups, respectively. In both groups, the majority of discontinuations from the study were for personal reasons, including lack of confidence in the method, messiness, partner's objection and a burning sensation. Few women reported a product-related complaint while using their assigned contraceptive method. The most commonly reported complaint for both methods was that use of the product led to an uncomfortable burning sensation for the woman and/or her partner. This complaint, however, was cited by less than 5% of the women in each group. Thus, a combination of low pregnancy rates, few complications and complaints and high continuation rates confirm the relative acceptability, effectiveness and short-term safety of these methods of contraception among this sample of Egyptian women.

Administration, Intravaginal↗
PubMed1983

Steroidal contraception in the '80s. The role of current and new products.

The future role of steroidal contraceptives in fertility management will be affected by rapid increases in population size in less-developed countries. Assuming that new serious risks with the use of steroidal contraception do not emerge and that radical, new technology does not replace this method, we can expect its continuing, important role in family planning programs. New compounds and delivery systems are now being studied. Within a few years a variety of long-acting and alternative delivery systems is likely to become available, including injectables and implants in biodegradable carriers and vaginal rings.

Adolescent↗
PubMedDate not supplied

Using randomized designs to evaluate client-centered programs to prevent adolescent pregnancy.

CONTEXT: Interventions to prevent adolescent pregnancy (primarily curriculum-based programs) have not produced convincing evidence as to their success. Moreover, many evaluation approaches have been inadequate to assess program effectiveness. Therefore, rigorous evaluation of different kinds of interventions may help identify potentially effective strategies to prevent adolescent pregnancy. METHODS: An experimental design, in which clients were randomized to treatment and control groups, was used to evaluate the effects of a "client-centered" approach to reducing pregnancy among high-risk young people in seven communities in Washington State. Four projects served 1,042 youth (clients aged 9-13), and three served 690 teenagers (primarily clients aged 14-17). Projects offered a wide variety of services tailored to individual clients' needs, including counseling, mentoring and advocacy. RESULTS: On average, clients in the treatment group at youth sites received 14 hours of service, and their teenage counterparts received 27 hours; controls received only 2-5 hours of service. At one youth site, clients were less likely to intend to have intercourse after the intervention than before; at another, they became less likely to intend to use substances. Clients at one teenage project reported reduced sexual behavior and improved contraceptive use after receiving services; teenagers at another site reported reduced sexual intentions and drug use, and a greater intention to use contraceptives. The programs showed no other effects on factors that place young people at risk of becoming pregnant, including their sexual values and educational aspirations, communication with their parents (measured at youth sites only), and sexual and contraceptive behavior (assessed for teenagers only). CONCLUSIONS: High-risk clients likely need considerably more intervention time and more intensive services than programs normally provide. Rigorous evaluation designs allow continued assessment that can guide program modifications to maximize effects.

Adolescent↗
PubMed1986

Contraception by Norplant subdermal capsules is not reliable in epileptic patients on anticonvulsant treatment.

The contraceptive efficacy of progestin-only contraception was studied in epileptic patients using NORPLANT subdermal capsules. The effect of anticonvulsants on levonorgestrel plasma levels was determined. NORPLANT subdermal capsules were inserted into nine epileptic women, and ten control women using no medication. Venous blood samples were taken at 0, 1, 3, 6, 9 and 12 months after insertion and the concentration of levonorgestrel was determined by radioimmunoassay. At 3 to 12 months, the overall mean concentration of plasma levonorgestrel was significantly lower in the six epileptics taking phenytoin alone or in combination with other anticonvulsants (203 +/- 128 pg/ml, mean +/- SD) than in the controls (325 +/- 135 pg/ml, p less than 0.01). After one year, nine of the control patients continued the use of NORPLANT and no pregnancies occurred. Two of the nine epileptics became pregnant during contraception by NORPLANT. They both used phenytoin and their plasma concentrations of levonorgestrel were low near the time of conception. Levonorgestrel released from the capsules had no apparent harmful effects on epilepsy and none of the patients reported an increase in seizure frequency. The results show that contraception by the progestin levonorgestrel is not reliable in epileptic patients using anticonvulsants known to induce metabolizing enzymes of the liver.

Adult↗
PubMed2005

Expressing medicine side effects: assessing the effectiveness of absolute risk, relative risk, and number needed to harm, and the provision of baseline risk information.

OBJECTIVE: To assess the effectiveness of absolute risk, relative risk, and number needed to harm formats for medicine side effects, with and without the provision of baseline risk information. METHODS: A two factor, risk increase format (relative, absolute and NNH)xbaseline (present/absent) between participants design was used. A sample of 268 women was given a scenario about increase in side effect risk with third generation oral contraceptives, and were required to answer written questions to assess their understanding, satisfaction, and likelihood of continuing to take the drug. RESULTS: Provision of baseline information significantly improved risk estimates and increased satisfaction, although the estimates were still considerably higher than the actual risk. No differences between presentation formats were observed when baseline information was presented. Without baseline information, absolute risk led to the most accurate performance. CONCLUSION: The findings support the importance of informing people about baseline level of risk when describing risk increases. In contrast, they offer no support for using number needed to harm. PRACTICE IMPLICATIONS: Health professionals should provide baseline risk information when presenting information about risk increases or decreases. More research is needed before numbers needed to harm (or treat) should be given to members of the general populations.

Adolescent↗
PubMed1999

UK accident and emergency departments and emergency contraception: what do they think and do?

OBJECTIVES: A postal questionnaire survey was conducted to assess what staff in UK accident and emergency (A&E) departments thought of providing an emergency contraception service, the degree of enthusiasm in and level of provision of the service, and staff attitudes to the introduction or continuation of provision of the service. METHODS: A questionnaire was sent to all 560 departments providing A&E services in the UK. RESULTS: Of the 560 units sent questionnaires, 355 (63.4%) replied. Half the units were located in small county towns, and a quarter in large towns. Requests for emergency contraception were received by 96% of responding units, but only 57% provided treatment. Requests for emergency contraception in 84 of these units ranged between one and 50 per month. The A&E senior house officer (SHO) and the gynaecology SHO and registrar prescribed most of the pills. Nurses were more involved in nurse led or general practitioner (GP) led units. Initial treatment only was given by 77% of providing units while the remainder also discussed subsequent contraception. Follow up was arranged with GPs by 92 units, and with family planning clinics by 66 units. Information packs were available in only 37 providing units. A total of 155 of providing units felt it was worthwhile and 56% of respondents thought emergency contraception should be provided by A&E departments. However, 91 units could identify one or more groups within the hospital who were antagonistic to provision by A&E departments, of which non-A&E medical staff formed the largest group. Over the counter availability of emergency contraception was not supported by 62% of respondents. CONCLUSION: The results show that while the female population appears to see a need for emergency contraception services to be provided in A&E departments, there is some reluctance by UK A&E departments to provide the service. Given the current interest in approaches to reducing unplanned pregnancies, especially in teenagers, provision of emergency contraception by A&E departments requires a pragmatic approach to ensure their cooperation in providing the service when alternative sources of provision are not available.

Attitude of Health Personnel↗
PubMed1998

Effects of ABT-761, a novel 5-lipoxygenase inhibitor, on the pharmacokinetics of a single dose of ethinyl estradiol and levonorgestrel in healthy female volunteers.

ABT-761 is a second-generation 5-lipoxygenase inhibitor in clinical development for the treatment of asthma. The effects of ABT-761 on the pharmacokinetics of an oral contraceptive were assessed in 21 female adult volunteers in a phase I, multiple-dose, open-label study. Subjects received a single dose of oral contraceptive (30 microg ethinyl estradiol and 0.15 mg of levonorgestrel) on each of days 1 and 29. Oral doses of 300 mg of ABT-761 were administered once daily beginning on day 15 continuing through day 29. Statistically significant decreases in maximum concentration (Cmax) and area under the concentration-time curve (AUC) of ethinyl estradiol were observed when oral contraceptive was administered concomitantly with ABT-761 compared with administration of oral contraceptive alone. The mean elimination rate constant of ethinyl estradiol increased by 30% (a mean decrease of 3.8 hours in half-life), and the mean apparent volume of distribution during the terminal phase (Vd(beta)/F) of ethinyl estradiol increased by 73% in the presence of ABT-761. Mean Cmax and AUC values for norgestrel decreased by 12% and 10%, respectively, when administered with ABT-761. Mean values for time to Cmax (tmax), terminal rate constant (beta), half-life (t1/2), and Vd(beta)/F of norgestrel were similar when oral contraceptive was administered alone or concomitantly with ABT-761. The mechanism responsible for the effect of ABT-761 on the clearance of ethinyl estradiol remains undefined. Because results of previous multiple-dose studies of ABT-761 do not provide any evidence of autoinduction, the effects of ABT-761 on the pharmacokinetics of ethinyl estradiol are more likely related to absorption of ethinyl estradiol.

Adult↗
PubMed1979

The use of a contraceptive vaginal ring governed by the pattern of individual uterine bleeding.

Contraceptive vaginal rings (CVR) releasing levonorgestrel and estradiol were used for contraceptive purposes in eight women. They were instructed to remove the CVR for five days only, in the case of bleeding. Three selected subjects were followed by plasma sampling during the first 60 days of treatment. Plasma concentrations of levonorgestrel, progesterone, estradiol and gonadotropins were determined. All subjects kept bleeding records and were controlled clinically in the course of treatment. The subjects were protected an average of 163 days by the CVR. Three subjects used the CVR 170--180 days without removing it and two subjects had to remove the CVR only once. Two subjects experienced quite regular bleedings, and metrorrhagic bleeding was present in one case. No pregnancies were observed during the follow-up period of 1304 days. Clinical examination revealed no pathological findings. The vaginal mucosa tolerated the treatment well. Out of those subjects who were followed by plasma sampling, pituitary suppression was more marked in the subject with continuous use of CVR.

Adult↗
PubMed1999

[Study on the relationship between first ovulation and infant feeding in lactating postpartum women].

OBJECTIVE: To determine the first ovulation after delivery and to provide scientific data for contraception in lactating postpartum women. METHODS: From January 1996 to December 1998, 101 lactating women were continuously monitored of their ovulation by ultrasound, basal body temperature (BBT) measurement and cervical mucus examination. RESULTS: The evidences of first ovulation (follicle > 1.8 cm in diameter) were found by ultrasound in 53 (52.5%) women during 154 days after delivery on the average and there were 11 (10.9%, 11/101) subjects who had first ovulation during 4 months after delivery and 42 (41.6%, 42/101) subjects had, after 4 months. Significant positive correlation was found between the time of supplementary feeding and the time of the first menses (n = 100, r = 0.4764, P < 0.01) and first ovulation (n = 53, r = 0.5554, P < 0.01). CONCLUSION: For postpartum mother it is suitable to begin with birth control method at the 4th month after delivery and to prolong the breast feeding is also a good method for birth control.

Adult↗
PubMed1999

Oral contraceptive health benefits: perception versus reality.

Many women remain unaware of classic oral contraceptive (OC) noncontraceptive health benefits even as new health advantages emerge from experience and research. An extensive body of evidence has established that OC protect women against dysmenorrhea and menorrhagia, menstrual cycle irregularities, iron deficiency anemia, ectopic pregnancy, pelvic inflammatory disease, ovarian cysts, benign breast disease, endometrial cancer, and ovarian cancer. In addition, the FDA has stated for the first time that an OC-triphasic norgestimate/35 micrograms ethinyl estradiol--is an effective treatment for moderate acne vulgaris. OC use also appears to prevent osteopenia in hypoestrogenic women. In addition to these noncontraceptive health benefits, OC have proven valuable in the management of a variety of gynecologic disorders, including dysfunctional uterine bleeding, persistent anovulation, premature ovarian failure, functional ovarian cysts, pelvic pain (including secondary dysmenorrhea), mittelschmerz, endometriosis, and the control of bleeding in women with blood dyscrasias. Educating healthcare providers and women about these important noncontraceptive health benefits will result in increased compliance, greater continuation, and fewer unintended pregnancies.

Acne Vulgaris↗
PubMed1982

[The results of cone biopsy of the cervix in women who have not yet reached the menopause ].

The authors have studied the post-operative gynaecological and obstetrical results of conisation of the cervix in young women. Their study is of 143 conisations of which part of the subject is found in 81 cases where conisation was the only treatment for the cervical lesion. Haemorrage was an important complication occurring in 3 out of the 81 cases. Conisation does not alter the fertility of these women, who will require contraceptive measures to be taken if they want to avoid terminations of pregnancy. Pregnancy when it does continue in these patients after conisation is sometimes beset by complications due to this operation. Abortion occurs in 18% of cases and premature labour in 6%. The incidence of these complications is directly related to the amount of tissue cut out. When conisation is carried out during pregnancy the results can be bad. In these cases a limited conisation must be performed, or if possible this surgical manoeuvre should be done only after delivery.

Abortion, Spontaneous↗
PubMed2006

Pregnancy attitudes and contraceptive plans among women entering jail.

Unplanned pregnancies are an important and costly public health problem. Women entering jail are at particularly high risk for unplanned pregnancies when they leave jail, given the high rates of poverty, substance abuse and sexually transmitted infections (STIs) in this population, all of which are associated with unplanned pregnancies. Attitudes toward pregnancy vary substantially, influencing openness of incarcerated women to starting a birth control method. This study was conducted as part of a Title X service evaluation and examined varying attitudes towards pregnancy and associated plans to use contraceptives. The current study included 223 women entering jail who were, under 36 years of age, fertile, sexually active with men, and not planning to become pregnant in the near future. Nearly half of the women had negative pregnancy attitudes (PAs), indicating that they did not want to become pregnant, while 41.3% endorsed ambivalent PAs. Compared to those with ambivalent PAs, those with Negative PAs were more likely to report a previous unplanned pregnancy (90.6% vs. 75.4%), a previous pregnancy termination (40.0% vs. 22.8%), and recent consistent use of contraceptives (37.0% vs. 21.7%). Women with negative PAs were significantly more likely to want to start or to continue a birth control method compared to those with ambivalent PAs (66% vs. 47%). Tailoring services to women's specific pregnancy attitudes during periods of incarceration may aid in preventing unplanned pregnancies in populations of high-risk women.

Abortion, Induced↗
PubMed1978

Contraception with long acting subdermal implants: I. An effective and acceptable modality in international clinical trials.

This paper presents results of a double blind, multi-centered and multi-national study of two progestin only subdermal implants used for contraception. A regimen of six capsules of levonorgestrel (Ng) used by 492 women had a net cumulative 12-month pregnancy rate of 0.6 percent and a continuation rate of 74.6 percent. 498 women used six capsules of norgestrienone (R2010) and experienced a net cumulative 12-month pregnancy rate of 3.5 percent and a continuation rate of 79.4 percent. The difference in the pregnancy rate was significant at P less than 0.01, while there was no significant difference in the continuation rates. Menstrual problems were the principal reason for termination of the levonorgestrel regimen, accounting for approximately half of all terminations. There were significantly fewer menstrual problems among users of the norgestrienone (R2010) capsules; the net cumulative 12-month termination rate for this reason was 4.3 percent. Results are compared with continuation and termination rates for acceptors of the Copper T 200 at the same clinics. The low pregnancy rate and reasonably high continuation rate of the norgestrel implants coupled with the fact that the expected effective lifetime of a set of capsules is of the order of 3-5 years appears to warrant further development of this contraceptive regimen.

Adolescent↗
PubMed1999

Use of placebo controls in an oral contraceptive trial: methodological issues and adverse event incidence.

Two multicenter, double-blind, placebo-controlled studies were conducted to evaluate the effectiveness of triphasic norgestimate/ethinyl estradiol (Ortho Tri-Cyclen) for the treatment of acne vulgaris. To our knowledge, these studies were the first double-blind, placebo-controlled trials to evaluate the efficacy of an oral contraceptive (OC) in the treatment of acne; in fact, they are probably the first placebo-controlled trials ever completed using modern OC. This article examines the conduct and feasibility of these studies including discussions on study planning enrollment, maintenance of the blind, continuation rates, and pregnancy prevention. Subjects were between the ages of 15 and 49 years, with moderate acne vulgaris, no contraindications to oral contraceptive use, and were willing to use a nonsteroidal method of birth control during the 6 months of the trial. More than 500 participants were enrolled in 1 year. Discontinuation rates between groups were similar. To explore the reasons for the similar and low discontinuation rates, OC-related side effects were evaluated in comparison to placebo. This analysis revealed that the OC exhibited a side effect profile that was similar, in many cases, to that of placebo. Although pregnancies occurred in the placebo arm, the incidence was consistent with expected failure rates for users of nonsteroidal methods in the general population.

Acne Vulgaris↗