Bleeding patterns of women using Lunelle monthly contraceptive injections (medroxyprogesterone acetate and estradiol cypionate injectable suspension) compared with those of women using Ortho-Novum 7/7/7 (norethindrone/ethinyl estradiol triphasic) or other oral contraceptives.

Persistent and/or unpredictable bleeding is a common reason for discontinuation of hormonal contraceptive methods. An open-label, nonrandomized, parallel, controlled study compared the efficacy, safety, and cycle control of the new, highly efficacious monthly injectable contraceptive containing 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate (E(2)C) (MPA/E(2)C) (Lunelle Monthly Contraceptive Injection) with that of the frequently used norethindrone 0.5, 0.75, 1.0 mg/0.035 mg ethinyl estradiol (NET/EE) triphasic oral contraceptive (Ortho-Novum 7/7/7). This report directly compares the bleeding patterns of women on MPA/E(2)C to those of women on NET/EE and untreated women. Overall, breakthrough bleeding occurred less frequently in women using MPA/E(2)C than in women using NET/EE (p < or =0.01). However, more women using MPA/E(2)C experienced amenorrhea/missed periods than those on NET/EE (p < or =0.01). In addition, the percentage of women experiencing breakthrough bleeding or amenorrhea while using other oral contraceptives is compared to that of women using MPA/E(2)C. A rapidly reversible method, MPA/E(2)C, combines the high contraceptive efficacy of surgical sterilization with the convenience of monthly administration. These data suggest that, for a large proportion of women, MPA/E(2)C offers predictability in bleeding patterns comparable to or greater than that experienced by ovulatory untreated women or those using combination oral contraceptives.

Comparative safety, efficacy, and cycle control of Lunelle monthly contraceptive injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension) and Ortho-Novum 7/7/7 oral contraceptive (norethindrone/ethinyl estradiol triphasic). Lunelle Study Group.

An open-label, nonrandomized, parallel, controlled study compared the efficacy, safety, and cycle control of a new monthly injectable contraceptive containing 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of estradiol cypionate (E2C) (MPA/E2C) (Lunelle Monthly Contraceptive Injection) with that of a norethindrone 0.5, 0.75, 1.0 mg/0.035 mg ethinyl estradiol (NET/EE) triphasic oral contraceptive (Ortho-Novum 7/7/7). At study enrollment, women chose either the injections or the oral contraceptive. A higher proportion of women in the NET/EE group (65.1%) than in the MPA/E2C group (48.7%) had used hormonal contraception during the month before the study (p < 0.01). Overall, 55.5% (434/782) of MPA/E2C users and 67.6% (217/321) of NET/EE users completed the 60-week trial. One-year contraceptive efficacy (13 cycles of 28 days) for MPA/E2C and NET/EE was based on 8008 and 3434 woman-cycles of use, respectively. During the first year, one pregnancy occurred in an NET/EE user for a life table rate of 0.3; no pregnancies occurred in users of MPA/E2C. One additional pregnancy in the NET/EE group occurred during the 15th treatment cycle. After the first treatment cycle, women in both groups experienced regular menses, with an average cycle length of 28 days in MPA/E2C users and 27 days in NET/EE users. Although MPA/E2C users were more likely to experience bleeding irregularities, only 2.5% (19/775) cited metrorrhagia as a reason for discontinuing treatment. The adverse events reported in both treatment groups are consistent with those expected with the use of combined hormonal contraceptives. Overall, the results of this first Phase III US clinical trial of MPA/E2C confirm this method's high contraceptive efficacy and safety, as shown in previous studies by the World Health Organization. These results suggest that a monthly combination injectable would represent a welcome new contraceptive option for women in the US.

[Effect of pretreatment counseling on discontinuation rates in women given depo-medroxyprogesterone acetate for contraception].

OBJECTIVE: To investigate the effect of pre-treatment counseling on discontinuation rates of 150 mg depo-medroxyprogesterone acetate (DMPA), given for contraception. METHODS: A total of 421 women participated, 204 receiving intensive structured pre-treatment and on going counseling on the hormonal effects and probable side effects of DMPA and 217 receiving only routine counseling. All participants were followed up at every 3 months for 1 year. The primary endpoint was termination rate, secondary endpoints were frequency of medical events and reasons for termination. RESULTS: The most common reasons for terminating DMPA were menstrual changes. Although women in the intensive structured counseling group reported more menstrual irregularity (39.7%) than did women in the routine counseling group (26.3%), study termination rates were significantly lower in the intensively structured counseling group than in the routine counseling group. At one year, the total cumulative termination rates were 11.3% (23/204) and 42.4% (92/217), respectively (P < 0.0001). No pregnancy and serious medical events were reported. CONCLUSION: Pre-treatment counseling on expected side effects increases the acceptability of DMPA.

A dose-response study of alprostadil sterile powder (S.Po.) (Caverject) for the treatment of erectile dysfunction in Korean and Indonesian men.

This open-label, dose-escalation study investigated the efficacy and safety of alprostadil (PGE1, prostaglandin E1) Sterile Powder (S.Po.) (Caverject) for treatment of erectile dysfunction (ED) in 84 men with ED of various etiologies lasting > or = 4 months. Doses started with 2.5 micrograms, then 5 micrograms, 10, 15, 20, 30, up to a 40 micrograms maximum. Eligible patients received single alprostadil injections in the physician's office until an erection occurred. Ten minutes after injection, the patient's erection was clinically evaluated. Optimal response was defined as erection sufficient to permit vaginal penetration and lasting 30-60 min. The patient also reported his own evaluation of response and any side effects. Patients were 24-65 y old (mean: 43.7 y), had ED of psychogenic, vascular, or neurogenic origin lasting 4 months-30 y (mean: 3.75 y). Of 84 patients enrolled, 82 completed the study. In the 82 patients who completed the study 78 (92.9%) achieved an optimal response; 18/78 patients (23.1%) had an optimal response at 2.5 micrograms, 9/78 (11.5%) at 5 micrograms, 21/78 (26.9%) at 10 micrograms, 12/ 78 (15.4%) at 15 micrograms, and 11/78 (14.1%) at 20 micrograms. Only 5/78 (6.4%) at 30 micrograms and 2/78 (2.6%) at 40 micrograms achieved an optimal response. Mean optimal alprostadil dose was 11.9 micrograms, and the mean minimal effective dose was 9.9 micrograms. Mean onset of erection was 11.2 min; mean duration of erection was 50.5 min. Penile pain in five patients (6%) was the only reported side effect.

Effect of pretreatment counseling on discontinuation rates in Chinese women given depo-medroxyprogesterone acetate for contraception.

The study examined the effect of pretreatment counseling upon discontinuation of 150 mg depo-medroxyprogesterone acetate (Depo-Provera (DMPA)), given for contraception. A total of 421 Chinese women participated, 204 receiving detailed structured pretreatment and ongoing counseling on the hormonal effects and probable side effects of DMPA and 217 receiving only routine counseling. The primary study endpoint was termination rate; secondary endpoints were frequency of medical events and reasons for termination. Study termination rates were significantly lower in the intensive structured counseling group than in the routine counseling group. At one year, the total cumulative termination rates were 11% (23/204) and 42% (92/217), respectively (p < 0.0001). The most common reasons for terminating DMPA were menstrual changes. No pregnancy, serious or unexpected medical events were reported, nor were statistically or clinically significant changes in vital signs observed. We conclude that pretreatment counseling on expected side effects increases the acceptability of DMPA.

PIP: In China, 214 women aged 18-40 years at two family planning clinics in Sichuan province received structured counseling on the effects they could expect with use of the contraceptive injectable delivering depot-medroxyprogesterone acetate (DMPA) and DMPA's mode of action. They also viewed an educational video on DMPA and received an information booklet on DMPA. 217 women aged 19-37 years at two other family planning clinics in the same province received routine counseling. They were only told that they were in a study to study the efficacy of DMPA. No other information on DMPA was provided unless asked. Researchers aimed to determine whether or not structured counseling would affect the rate of DMPA discontinuation. They followed the women for 12 months. Overall, the women who received structured counseling had a much lower discontinuation rate than those who received routine counseling (p 0.0001). For example, three months after receiving the first DMPA dose, 3% of women in the structured counseling group did not return for the next DMPA dose compared to 25% of those in the routine counseling group. At 12 months, these figures were 11% and 42%, respectively. Regardless of the group, menstrual irregularities were the leading reasons for DMPA termination and were much more common as a reason in the routine counseling group than the structured counseling group (19.24% vs. 5.43%; p 0.0001). They were also the most commonly reported medical event for both groups (39.7% for structured counseling group and 26.3% for routine counseling group). Among breast feeding mothers, menstrual irregularities were less likely to be a reason for DMPA termination in the structured counseling group than the routine counseling group (14% vs. 37%). Increased body weight and changes in blood pressure were not found. No pregnancy or serious or unexpected side effects occurred. These findings suggest that structured counseling increases the acceptability of DMPA and that DMPA is safe and effective.

The use of alprostadil sterile powder in a home self-injection study of Asian men with erectile dysfunction.

This study evaluated the individual optimal dose of alprostadil in the office setting that could be used as the basis for effective home self-injection therapy. The study included 150 Asian men with erectile dysfunction (ED). The mean age of study participants was 48.3 years (range, 21 to 74 years), and the mean duration of ED was 3.6 years. The most common cause of ED was venogenic (24%), psychogenic (21%), arteriogenic (13%), neurogenic (0.7%), or a combination of these (41%). An optimal response was seen in 72% of patients (n = 108) in the office and 96% of patients (n = 100) at home. The mean +/- SD office dose of alprostadil was 19.4 +/- 12.8 micrograms versus 18.0 +/- 12.2 micrograms at home. More than half of the patients (57% in an office setting and 53% at home) achieved an optimal response at a dose between 5 and 15 micrograms. By the 20-micrograms dose, 82% of patients had achieved an optimal dose at home compared with 70% of patients in the office. An optimal response was seen at the same dose in the office and home in 75% of patients; the dose at home decreased from the office dose for 16% of the patients and increased for 9%. There were 24 patients who experienced adverse events: penile pain after injection (18 patients), cold sweating (2 patients), pediculosis (1 patient), broken leg (1 patient), ankle pain (1 patient), and prolonged erection (1 patient). One patient discontinued the study because of penile pain. Alprostadil sterile powder offered safe and effective treatment of ED for home self-injection therapy. Once an optimal dose response had been established in the physician's office, further home adjustments were needed in 25% of patients. Penile pain, usually mild, was the most common, possibly related adverse effect reported.