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PubMed2001

Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial.

CONTEXT: Oral contraceptive (OC) pills are effective, but poor compliance increases rates of pregnancy during treatment. OBJECTIVE: To compare the contraceptive efficacy, cycle control, compliance, and safety of a transdermal contraceptive patch and an OC. DESIGN: Randomized, open-label, parallel-group trial conducted October 1997 to June 1999. SETTING: Forty-five clinics in the United States and Canada. PARTICIPANTS: A total of 1417 healthy adult women of child-bearing potential. INTERVENTIONS: Participants were randomly assigned to receive a transdermal contraceptive patch (n = 812) vs an OC (n = 605) for 6 or 13 cycles. Patch treatment consisted of application of 3 consecutive 7-day patches followed by 1 patch-free week. MAIN OUTCOME MEASURES: Overall and method-failure Pearl Indexes (number of pregnancies/100 person-years of use) and life-table estimates of the probability of pregnancy were calculated. Cycle control, compliance, patch adhesion, and adverse events were also assessed. RESULTS: Overall and method-failure Pearl Indexes were numerically lower with the patch (1.24 and 0.99, respectively) vs the OC (2.18 and 1.25, respectively); this difference was not statistically significant (P =.57 and.80, respectively). The incidence of breakthrough bleeding and/or spotting was significantly higher only in the first 2 cycles in the patch group, but the incidence of breakthrough bleeding alone was comparable between treatments in all cycles. The mean proportion of participants' cycles with perfect compliance was 88.2% (811 total participants, 5141 total cycles) with the patch and 77.7% (605 total participants, 4134 total cycles) with the OC (P <.001). Only 1.8% (300/16 673) of patches completely detached. Both treatments were similarly well tolerated; however, application site reactions, breast discomfort, and dysmenorrhea were significantly more common in the patch group. CONCLUSION: The contraceptive patch is comparable to a combination OC in contraceptive efficacy and cycle control. Compliance was better with the weekly contraceptive patch than with the OC.

Administration, Cutaneous↗
PubMed2006

Adolescents' descriptions of the physical characteristics of microbicide surrogates and experiences of use.

PURPOSE: Our purpose was to describe adolescent girls' perceptions of microbicide surrogates and experiences of use, including impact on sexual pleasure. METHODS: Sexually experienced girls, 14-21 years, were recruited for a study examining microbicide acceptability. The girls were given vaginal moisturizers (gel or suppository) to use as if they were microbicides. Girls (n = 175) discussed their perceptions and experiences of use of these products in response to semistructured interviews. Girls were asked at weekly phone interviews about the impact of product use on their and their partners' sexual pleasure. These answers were averaged, and girls were categorized into those for whom the product predominantely made sex feel worse, better less than half the time, or better half the time or more. The relationship of demographics and sexual history to the impact on pleasure was evaluated. RESULTS: Overall, participants were positive about their experience with the products. More girls preferred the gel. Specific concerns about the suppository included the wait period, texture, and messiness of self-insertion. Many liked the lubricating quality of both of the surrogates. Girls discussed messiness, leakage, clumping, and the difficulties in communicating with partners. Over half reported an increase in pleasure most of the time for themselves and their partners. None of the demographic and sexual history predictors were significantly related to impact on pleasure. CONCLUSIONS: Anticipatory guidance should help girls initiate and sustain use. Future research should examine the best way to accomplish counseling about microbicide use with adolescent girls.

Administration, Intravaginal↗
PubMed1985

Menstrual migraine, old and new.

The authors reviewed the connection between sexual hormones and migraine crisis. Besides other exogenous factors, the fall of estradiol blood levels in the late luteal and premenstrual phase seems a causal factor in the origin of menstrual-related headache crisis. The behaviour of migraine crisis during the various events of female reproductive life, support this view. The role of PRL, T, FSH and LH was also discussed. On the other hand, menstrual migraine represents a model that fits perfectly with a neuroendocrine hypothesis which is based upon a faulty chronobiological response of the so-called antinociceptive system.

Contraceptives, Oral, Combined↗
PubMed1995

The female condom (Femidom)--a study of user acceptability.

OBJECTIVE: To determine the acceptability of the female condom (Femidom). DESIGN: Questionnaire survey following the use of the Femidom during sexual intercourse. SETTING: Groote Schuur and Somerset Hospitals, Cape Town. PARTICIPANTS: Nurses, secretaries, doctors and domestic staff of Groote Schuur and Somerset Hospitals who volunteered-61 women were recruited, 8 did not use any female condoms, and 1 did not return. Many women refused, mainly because of the unaesthetic appearance of the Femidom and the fact that they had to continue using their regular contraceptive and they did not think their partners would co-operate. OUTCOME MEASURES: Sexual responsivity compared with that without Femidom; acceptability of the method; women's and their partners' enjoyment of using the method; comparison with the male condom; awareness of HIV-AIDS and protective measures that can be used. RESULTS: Of the 52 participants, 23 used all 10 Femidoms issued to them. Thirteen women and 18 of their partners did not enjoy using the method and 9 had problems with it. Sex with the Femidom was the same or better in 51.9%. The Femidom was unacceptable in 32.7%, acceptable in 52% and very acceptable in 13.4%. Compared with the male condom, 50% of women and 44.2% of men considered the Femidom as good or better. Of the 61 women, 59 had heard of AIDS, and awareness of protective measures was good. CONCLUSION: There was resistance to accepting the Femidom, mainly because of its unaesthetic appearance and because women were participating for altruistic reasons. Acceptance and ease of application improved with use. Comments regarding problems and subjects' and their partners' enjoyment varied from extremely positive to extremely negative; 65.4% considered sex using the Femidom acceptable or very acceptable. It is important to inform and obtain co-operation from the male partner. The female condom has been developed as an alternative for women to use if their partners refuse or dislike using male condoms. Perfect use of the Femidom may reduce the annual risk of acquiring HIV by more than 90% in women who are sexually active with an infected male. The efficacy of the female condom has been described as equal to that of the diaphragm. The Femidom will increase the range of choices of contraceptives and prophylactic methods available for protective sex. It should become accepted as a method of contraception and an adjunct to other contraceptive methods as a prophylactic against sexually transmitted diseases and AIDS, particularly in relationships that are not mutually monogamous.

Adult↗
PubMed2004

An evaluation of the use of the transdermal contraceptive patch in adolescents.

PURPOSE: To evaluate the acceptability and feasibility of using the new transdermal contraceptive patch in adolescents. METHODS: A 3-month longitudinal trial using the Ortho Evra transdermal contraceptive patch in 50 adolescent girls. All healthy girls aged 15-18 years were invited to participate from two San Francisco Bay Area teen clinics. Participants were followed after 1 month and 3 months of treatment. Data were collected on patch detachments, perceived advantages and disadvantages, side effects, and compliance. Data were analyzed using Student's t-test (SPSS). RESULTS: Forty participants (80%) completed 1 month of treatment and 31 (62%) completed all 3 months of the study. There were no pregnancies during treatment. At the 3-month follow-up, 87.1% of participants reported perfect compliance. Ease of use, the fact that it does not require daily attention, and the ease of concealment were among the main reported advantages. Roughly 77% of participants who completed the study were planning to continue using the patch. The 35.5% rate of complete or partial detachment of at least one patch was considerably higher than reported in previous studies of adults. As in adults, the most commonly reported complaints were application site reactions and breast discomfort. CONCLUSIONS: This evaluation found an overall positive impression of the new transdermal contraceptive patch, with good rates of short-term compliance and few side effects among adolescents. However, the high degree of detachment unique to this sample of adolescents is concerning and requires further evaluation.

Administration, Cutaneous↗
PubMed1997

Female condoms.

Early versions of a female condom were available in the 1920s and 1960s, but they were little used and soon forgotten. It took the arrival of AIDS, and the urgent need for a wider range of female-controlled barrier techniques, to rekindle scientific interest in this method. In the 1980s, three groups in Europe and the USA began development of new female condom designs, comprising 'Femidom (Reality)', the 'Bikini Condom', and 'Women's Choice'. Apart from differences in their physical design, Femidom differs from the others in that it is made of a polyurethane membrane, which has several advantages over latex. Of the three, Femidom is the most advanced in terms of development and clinical testing, and it is the only one to have reached the marketing stage. Laboratory studies and clinical trials suggest that its contraceptive efficacy is similar to that documented for the male condom, though a direct comparison is not possible because no comparative clinical trials have, as yet, been undertaken. Reported 'typical-use' pregnancy rates range from 12.4 to 22.2% at 6 months of use in the USA and Latin America, respectively, while a study in the UK observed a rate of 15% at 12 months. As with all barrier methods, most failures appear to be associated with poor compliance or incorrect use. 'Perfect-use' pregnancy rates were substantially lower, indicating that Femidom can be very effective, if used consistently and correctly. Evidence for Femidom's effectiveness to protect against transmission of sexual disease-causing organisms, including HIV, is still very limited and based largely on laboratory studies. Whilst, in theory, the condom should confer reliable protection, its efficacy in clinical use will depend upon correct and consistent use and upon the product's ability to maintain an effective physical barrier throughout penetrative intercourse. In this respect, the results of recent and ongoing clinical studies are expected with much interest. How valuable Femidom will prove to be, in terms of sexual health and contraception, will also depend largely on its long-term user-acceptability. As is generally the case with new methods, initial public interest in Femidom is expected to be high, as was documented in numerous surveys, and there undoubtedly exists a sub-group of women who view the product as their most appropriate contraceptive/sexually transmitted disease prevention option. However, more information on the product's acceptability, based on continuation rates, as is usually applied to other contraceptive techniques, is urgently needed to permit a more reliable assessment of Femidom's position among current methods. The arrival of a female condom represents a welcome addition to the range of female-controlled barrier contraceptives and, because of its numerous potential advantages over the male condom, may play an important role in the prevention of unwanted pregnancy and sexually transmitted diseases.

Single-Use Internal Condom↗
PubMed2004

[Intergamete complementarity: short review].

OBJECTIVE: The aim of this review is to recognize the role of molecules involved in intergamete interactions during the process of fertilization and further understanding of the molecular basis of fertilization in humans for the development of new methods for contraception. METHODS: We carried out a bibliographic review on intergamete interactions. RESULTS: Fertilization is the product of a series of ordered steps that must take place both in the sperm and the oocyte for a correct interaction leading to the development of the new individual; this interaction requires that both cells are in perfect state for recognition to occur; this recognition is dependant on terminal oligosaccharide residues present in zona pellucida and their complementary receptors on sperm plasmatic (primary receptors) and inner acrosomal (secondary receptors) membranes. CONCLUSIONS: Knowledge of these processes will provide a better understanding of the molecular mechanisms in intergamete interaction and could lead to the development of tools for controlling reproduction as well as for helping couples presenting alterations of their

Female↗
PubMed1991

Is diathermy safe in women with copper-bearing IUDs?

Ultrasound and short-wave diathermy are widely used in physiotherapy to induce heating of deep tissues, since this causes a concomitant increase in local blood flow. A metallic implant in the treated field is generally regarded as a contra-indication to diathermy because of the risk of thermodamage to surrounding tissues. It is not certain, however, if copperbearing IUDs contain sufficient metal as to constitute a risk. In order to exclude the possibility that diathermy might lead to intra-uterine burns in women using copperbearing IUDs a technique was devised of measuring temperatures in the copper wire of an IUD in situ during short-wave an ultrasonic therapy. The results indicate diathermy to be perfectly safe in women whit copper-bearing IUDs.

Body Temperature↗
PubMed1989

GnRH agonists.

The development of GnRH agonists has had a major impact on the practice of gynecology and reproductive endocrinology. The clinical usefulness of GnRH agonists will increase as modes of administration are improved and indications become better defined. GnRH agonists and, potentially, antagonists will provide a prompt, effective, and reversible method of suppressing ovarian function. GnRH agonists may soon become a treatment of choice for many of the noncontraceptive uses of oral contraceptives. Current indications for GnRH agonist administration are best divided into two groups: short-term (less than 6 months) and long-term (greater than 6 months) suppression. Short-term administration of GnRH agonist include most of the current usage of GnRH agonists. Short-term administration avoids most of the side effects of GnRH agonist and offers the most potential for development of GnRH antagonists. Short-term therapy has been shown to be particularly effective in the preoperative treatment of fibroids, suppression of ovarian function before ovulation induction, for short-term suppression of endometriosis, and for diagnostic purposes to determine whether a medical illness is related to ovarian function. Chronic administration of GnRH agonist has produced varying degrees of success. The treatment of precocious puberty is probably the perfect indication for GnRH agonist suppression. The disease is completely reversed with a remarkable absence of side effects. Long-term administration for metastatic breast or prostatic cancer has been shown to be as efficacious as other forms of gonadal suppression and the potential benefits of suppression outweigh the potential side effects of long-term suppression. The risk-benefit ratio must be carefully analyzed for the other indications for long-term suppression. Long-term suppression could be used for medical illnesses exacerbated by the menstrual cycle, painful symptoms related to endometriosis, contraception, and suppression of hyperandrogynism. Although initial studies show the agonist to be quite effective in treating all of these disorders, long-term suppression also may result in potential serious side effects related to hypoestrogenism including hot flashes and osteoporosis. Long-term administration of GnRH agonist may become feasible by lowering the dose and degree of suppression or by combining GnRH agonist with estrogen or progestin replacement, or both.

Female↗
PubMed2001

[Diagnosis and follow-up of endometriosis during consultation: changes].

In a literature review, news in symptomatology and follow-up of endometriosis were analyzed (infertility, pain, hemorrhage, adnexal tumors). Survey and examination can be made with improved quality (pain scale, menorragha scheme of Higham). Diagnosis and follow-up of endometriosis are more perfect by ultrasonographical examination by the gynecologist in his office. Ultrasonography is better for endometrioma and adenomyosis than other localisation (complementary explorations-magnetic resonance imaging, outside of consultation, are useful for deeper and superficial lesions). In follow-up, clinical research and ultrasonic exploration show the true relapses. Treatment's observance and success will be improved by ultrasonic analysis. Intolerances, add-back therapy, contraception, substitutive hormonal treatment of menopauses and cancer risk, are different problem and solution will be offer.

Endometriosis↗
PubMed1976

Application of social science theories to family planning health education in the People's Republic of China.

The transformation of the Chinese society was political and economic by revolution; it was also social and cultural through mass education. Group decisions have been used to induce social change in the Chinese society and applied extensively to the family planning program. The methods which Kurt Lewin developed to change food habits, have been perfected on a grand scale of myriad ways by the Chinese.

Adult↗
PubMedDate not supplied

The demographic impact of family planning programs.

In response to concerns about the adverse consequences of rapid population growth, family planning programs have been implemented in many developing countries. The aim of the present study is to assess the impact of this programmatic approach on long-range population growth. The result of a new and hypothetical population projection indicates that in the absence of family planning programs the population of the developing world could be expected to reach 14.6 billion in the year 2100 instead of the 10 billion that is currently projected by the World Bank. Despite the apparent success of existing interventions, fertility control is far from complete, as many women continue to bear unwanted births. To assess the impact of this unintended childbearing a second hypothetical projection is made. With perfect implementation of reproductive preferences, the population size of the developing world in 2100 would be reduced by an estimated 2.2 billion below the current projection. Further strengthening of family planning programs and improvements in birth control technology are therefore likely to provide important demographic benefits.

Contraception Behavior↗
PubMedDate not supplied

Natural family planning with and without barrier method use in the fertile phase: efficacy in relation to sexual behavior: a German prospective long-term study.

A large prospective long-term study with users of natural family planning (NFP) methods has been conducted to analyze the relation between unintended pregnancy rates and sexual behavior with special reference to barrier method use in the fertile phase. Seven hundred and fifty eight NFP beginners, 19-45 years of age, 14870 cycles, 28 unintended pregnancies were studied. Of the couples, 54.2% use NFP only or predominantly and 45.9% use mixed methods (additional barrier method use in the fertile phase in 55.7% of the cycles). The overall pregnancy rate after 12 cycles of exposure is 2.2% according to the actuarial method. There is no significant difference between NFP users and mixed methods users and also no significant effect of duration of use in the first 5 years of exposure. During "perfect use" the pregnancy rate at 12 months is 0.63%. When only protected intercourse takes place in the fertile phase the pregnancy rate is 0.45%. The symptothermal method of NFP is most unforgiving for imperfect use (unprotected intercourse in the fertile phase). However, it is extremely effective when either abstinence or protected intercourse is used in the fertile phase.

Adult↗
PubMed1989

Effectiveness of the cavity-rim cervical cap: results of a large clinical study.

From 1981-1988, 3433 women were fitted with a cavity-rim cervical cap in a Food and Drug Administration-approved study. The estimated first-year pregnancy risk was 11.3% (95% confidence limits 10.0-12.8), with risks of 8.3 and 3.8% for user and method failures, respectively. Women who were younger, less educated, and more sexually active, and who intended to have children in the future, had higher pregnancy risks. "Near-perfect" users, ie, individuals who wore the cap for a maximum of 72 hours, used spermicide 100% of the time, and did not report unprotected sexual intercourse, had half the first-year pregnancy risk of others (6.1 versus 11.9%). There were no serious medical or gynecologic complications associated with cap use, although over 20% of users reported problems with cap dislodgment during or after intercourse, cap malodor, or partner discomfort.

Adult↗
PubMed1989

Tubal desterilization through exclusive laparoscopy.

The first case of tubal desterilization after Yoon rings through exclusive laparoscopy is reported. Yoon ring tubal segment excision was performed with CO2 laser and coelioscopic scissors, after mesosalpinx haemostasis by ornithine--vasopressin infiltration. Tubal anastomosis was managed with biological glue on an intraluminal guide which was pulled out after 48 h. Follow-up hysterosalpingography 3 months later showed perfect tubal patency. This case proves that complete tubal reversal by exclusive coelioscopy is possible. At present, this procedure is restricted to only one tube during coelioscopic evaluation, preserving, in case of failure, the chance of microsurgery either on the contralateral tube or even on the previously operated one. The advantages of such a technique are those of coeliosurgery: no laparotomy, shortened hospitalization and minimal post-operative adhesions. Since this first case, others have been performed. It is still too early to appreciate the results in terms of intrauterine pregnancy.

Adult↗
PubMed1984

Volumetric vaginal aspirator may aid in natural family planning.

All natural family planning (NFP) methods are based on the determitnation of a woman's fertile period so that a couple may abstain from sexual relations or use a mechanical means of birth control during that time. Researchers are seeking more accurate methods of predicting the onset of ovulation in order to increase the effectiveness of NFP. A new device developed by Dr. Gebhard F.B. Schumacher, a fertility specialist at the University of Chicago who serves on FHI's Technical Advisory Committee, and Dr. Stepen J. Usala, a former medical student at the University's Pritzker School of Medicine, holds the promise of providing a new, cheap, and relatively simple way of predicting ovulation. Called a volumetric vaginal aspirator, the instrument allows women to measure their own vaginal fluid on a daily basis. In early studies of 7 women carefully studied over 18 menstrual cycles, a striking 3 fold to 30-fold increase in the volume of vaginal fluid occurred a few days before ovulation. Results from 12 more women for a total of 26 cycles confirmed the earlier studies. Blood samples were taken in order to measure the levels of estrogen, known to increase prior to ovulation, and luteinizing hormone, which peaks sharply on the day of ovulation, in the women studied. These confirmed that ovulation typically had occurred after the fluid volume increase. In addition, participants recorded their basal body temperature (BBT) upon awakening. Although the BBT does not predict ovulation, it frequently increases by 1/2-1 degree Fahrenheit after ovulation thus serving as an indicator of the end of the fertile period. The prototype of the vaginal aspirator is a disposable plastic syring marked at .05 milliliter intervals so that fluid levels can be easily measured. After the manufacturing process for the aspirator is perfected so that the instrument can be mass produced, Dr. Schumacher hopes that largescale clinical trials will be initiated in the US and abroad. The larger studies and an endocrine study are needed in order for effective rules to be developed for applying the method in either birth control or fertility enhancement. The vaginal aspirator could be useful not only for preventing unplanned pregnancy but also for aiding couples experiencing infertility to pinpoint the time that conception is most likely to occur. As an aid in birth control, the aspirator should have a success rate similar to or better than that of a diaphragm, Dr. Schumacher believes. Although the women testing the vaginal aspirator were ablet to use it without assistance, Dr. Schumacer emphasizes that some patient education will be necessary if it becomes commercially available. Fertility awareness teachers could incorporate it into their courses. Research on the volumetric vaginal aspirator has been supported by FHI and by Mothers' Aid Research Fund of Chicago Lying-In Hospital.

Clinical Laboratory Techniques↗