Fertility awareness-based methods for contraception: systematic review of randomized controlled trials.

CONTEXT: Fertility awareness-based (FAB) methods of family planning estimate the fertile days of the menstrual cycle whether by observing fertility signs such as cervical secretions and basal body temperature or by monitoring cycle days. The efficacy and acceptability of these methods are unclear. METHODS: We retrieved and analyzed all randomized controlled trials that examined any FAB method used for contraception. RESULTS: Because of poor methods and reporting, pregnancy rates could not be determined. A trial in Colombia found similar numbers of pregnancies among women randomized to the ovulation and symptothermal methods, but a trial in Los Angeles observed more pregnancies in the group assigned to the ovulation method. In the two American trials, recruitment of participants was unexpectedly difficult. Continuation rates were poor. CONCLUSION: Despite intensive training and ongoing support, most participants in these trials discontinued prematurely. The comparative efficacy of these methods remains unknown. However, with the ovulation and symptothermal methods, pregnancies appear to be common; method continuation rates are low.

Steroid hormones for contraception in men: systematic review of randomized controlled trials.

Male hormonal contraception has been an elusive goal. Administration of sex steroids to men can shut off sperm production through effects on the pituitary and hypothalamus. However, this approach also decreases production of testosterone, so an "add-back" therapy is needed. We conducted a systematic review of all randomized controlled trials of male hormonal contraception and azoospermia. Few significant differences emerged from these trials. Levonorgestrel implants combined with injectable testosterone enanthate (100 mg im) were significantly more effective than was levonorgestrel 125 microg po daily combined with testosterone patches [10 mg/d; odds ratio (OR) for azoospermia with the oral levonorgestrel regimen, 0.03; 95% CI, 0.00-0.29]. The addition of levonorgestrel 500 microg po daily improved the effectiveness of testosterone enanthate 100 mg im weekly by itself (OR for azoospermia with the combined regimen, 4.0; 95% CI, 1.00-15.99). Several regimens, including testosterone alone and gonadotropin-releasing hormone agonists and antagonists, had disappointing results. In conclusion, no male hormonal contraceptive is ready for clinical use. All trials published to date have been small exploratory studies. As a result, their power to detect important differences has been limited and their results have been imprecise. In addition, the definition of oligospermia has been imprecise or inconsistent in many reports. To avoid bias, future trials need to pay more attention on the methodological requirements for randomized controlled trials. Trials with adequate power would also be helpful.

Use of a levonorgestrel-releasing intrauterine system to treat bleeding related to uterine leiomyomas.

OBJECTIVE: This study was designed to evaluate the potential usefulness of the levonorgestrel-releasing intrauterine system (LNG IUS) in treating women with uterine leiomyomas. DESIGN: Prospective before-and-after study. SETTING: Family planning unit in an academic research institute. PATIENT(S): Sixty-seven women with uterine leiomyomas who chose the LNG IUS as their method of contraception. INTERVENTION(S): Clinical and ultrasound examinations were performed prior to and 3, 6, and 12 months after the LNG IUS insertion. MAIN OUTCOME MEASURE(S): Menstrual blood loss assessed with pictorial blood loss assessment charts, ferritin and hemoglobin concentrations, and uterine and leiomyoma volume. RESULT(S): Use of the LNG IUS was associated with a marked reduction in menstrual blood loss. After 12 months of use, the mean pictorial blood loss assessment chart score declined from 97 to 16 (P<.001). Hemoglobin and ferritin levels increased significantly over 1 year of use. Eighteen of 19 women (95%) who were anemic at the beginning of the study were no longer anemic at 12 months, as judged by hemoglobin levels. No pregnancies occurred during the study. CONCLUSION(S): The LNG IUS was associated with a profound reduction in menstrual blood loss. For women with leiomyomas of this size, the LNG IUS provides effective medical treatment of bleeding.