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More than 300 subscribers of Contraceptive Technology Update (CTU) completed the questionnaire for the 1994 Pill Survey. Most respondents (68%) were nurse practitioners followed by physicians (11%), registered nurses (9%), and physician assistants (4%). 92% of respondents considered oral contraceptives (OCs) (especially Ortho-Cept and Ortho Novum 7/7/7) as the leading hormonal contraceptive choice among adolescents and adults. Among teens, Depo-Provera was the second choice (4%). Among adults, Depo-Provera and the contraceptive implant, Norplant, fared equally as well (2% each). Headaches, mood swings, and weight gain continued to be complaints for all hormonal contraceptives. Progestins are potent depressants. Norplant produced the most complaints. About 20% of providers reported that at least 20% of their patients wanted Norplant implants removed because of significant side effects, especially irregular bleeding. Most Norplant users had the implants for no more than 12 months. The providers realized that they were providing insufficient counseling to Norplant users about irregular bleeding before insertion. A physician noted that some women experience infertility for as long as two to three years after their last Depo-Provera injection. Some providers discourage women from using Norplant based on the many complaints they have received from past users.
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PMID:Depo-Provera and Norplant implants prove no competition for no. 1 choice, OCs. The 1994 pill survey. 1228 3

Modeled after the naturally occurring hormone progesterone, progestins are the synthetic hormones used in Norplant, depot-medroxyprogesterone acetate (DMPA), and progestin-only pills (POPs). Progestin-only contraceptives alter a woman's hormonal balance. In so doing, progestin-only contraceptives block a series of chemical signals essential to the completion of a normal reproductive cycle, either by blocking the release of an egg or by making its fertilization and implantation within the uterus unlikely. In many women, progestin-only contraceptives stop the monthly release of an egg. Even if an egg is released, progestin makes its movement through the fallopian tubes into the uterus more difficult. Progestin also thickens the mucus in the cervix, which stops sperm from penetrating the mucus and reaching an egg. In the unlikely event that ovulation does occur and an egg becomes fertilized, the hormonal disruption makes the lining of the uterus inhospitable for implantation. This multiple mode of action therefore makes progestin-only methods among the most reliable of all contraceptives. Norplant and progestin-only injectables have failure rates of less than 1%, while POPs are typically 95% effective. Sections discuss ovulatory suppression, physiological changes, weight gain and headaches, health concerns, and counseling before use.
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PMID:Progestin-only methods are very effective. 1228 32

A 6-month prospective study of 120 clients of the Bulgarian Family Planning Association was undertaken to document the use, effectiveness, and side effects of the postcoital contraceptive Postinor. 40 of the women used Postinor during 6 cycles, 31 during 5 cycles, 29 during 4 cycles, and 20 during 3 or fewer cycles (total of 570 cycles). Most took 1 tablet within an hour of each intercourse (they were instructed not to use the method more than 4 times per month), but some took 2-4 tablets simultaneously. This misuse resulted in badly tolerated side effects. Side effects occurred in 50% of the clients and included bleeding, delayed menstruation, nausea, headaches, breast tenderness, severe menstrual bleeding, irritability, and weight gain. Four of the subjects became pregnant (these women took the pill a day or more after intercourse). The side effects occurred more frequently in the women who took the most tablets during a month. It was concluded that Postinor should be reserved for emergency use and that clients must be properly counseled about its use and side effects.
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PMID:Prospective study of contraception with levonorgestrel. 1229 Aug

The acceptability and effectiveness of a progestogen-only oral contraceptive (OC), Ovrette, during lactation were investigated in 200 women recruited from a teaching hospital in Khartoum, Sudan. Ovrette contained 0.075 mg of norgestrel. 69 women (34.5%) had used OCs at some point prior to the index pregnancy. Serious complications (e.g., severe headache, chest pain, leg pain, abdominal pain, blurred vision) were reported by 8 respondents during the 12-month study period. Less serious side effects included dysmenorrhea (49 women), nausea (28 women), dizziness (38 women), vaginal discharge (86 women), headaches (78 women), and breast discomfort (21 women). Overall, 143 women (71.5%) experienced at least 1 side effect. Of the 21 women (10.5%) who discontinued Ovrette use before 12 months, 9 were motivated by menstrual problems and other side effects. The 12-month continuation rate was 89.1%. There were 2 pregnancies, only 1 of which represented method failure. These findings are consistent with previous studies indicating that use of progestin contraceptive agents is associated with more menstrual disturbances and pregnancies than combined OCs. Use of combined OCs is contraindicated during lactation, however.
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PMID:A study of a progestogen only oral contraceptive for lactating women in Khartoum, Sudan. 1229 69

Wyeth-Ayerst Laboratories recently introduced Alesse, a 20 mcg monophasic oral contraceptive pill available in 21- and 28-day regimens. The pill is comprised of 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel. Alesse was recently cleared for release by the US Food and Drug Administration (USFDA). A multicenter clinical trial involving 1477 women aged 17-49 years found the pill to provide good cycle control. Headache was the most common side effect noted by women in the trial. The only other 20 mcg pill, Loestrin 1/20, manufactured by Parke-Davis, also uses ethinyl estradiol for its estrogen, but 1 mg of norethindrone acetate as its progestin. The availability of such low-dose pills is particularly important for women in their later contraceptive years. These women may need contraception as well as relief from perimenopausal symptoms. The USFDA also cleared Alesse for use as an emergency contraceptive pill, the seventh brand approved by the agency for such use.
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PMID:Wyeth-Ayerst introduces Alesse; OC expands range of low-dose pills. 1229 28

A 1997 Contraceptive Technology Update survey of 145 US family planning practitioners found that oral contraceptives (OCs) remain the leading reversible contraceptive method, chosen by 85% of adult women and 78% of teenagers. Ortho Tri-Cyclen is the first choice among OC brands, presumably because of its recent US Food and Drug Administration endorsement for acne control. Ortho Tri-Cyclen is the first low-dose OC to be indicated for noncontraceptive use. 11% of adult women and 17% of teenagers preferred Depo-Provera in 1997, compared with 6% and 11%, respectively, in 1996. Another study, commissioned by the US Association of Reproductive Health Professionals, indicated 85% of current OC users are very satisfied with the method and 50% of former users still prefer it over other forms of birth control; 75% would advise a young woman to use OCs. Although weight gain, severe headaches, and mood swings may affect users of OCs, Depo-Provera, and Norplant, OC users are less likely to discontinue method use because of these side effects than users of implants and injectables.
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PMID:Oral contraceptives hold top position as leading choice for women. 1229 67

Another low-dose oral contraceptive (OC), Levlite, has received US Food and Drug Administration approval. Levlite, manufactured by Berlex Laboratories, contains 20 mcg ethinyl estradiol and 100 mcg levonorgestrel. Alesse, an OC manufactured by Wyeth-Ayerst, has the same components. Two other OCs--Loestrin and Mircette--contain 20 mcg ethinyl estradiol, but differ in their progestin component or dose. A pill containing 20 mcg ethinyl estradiol provides women with 33% less estrogen than a 30-mcg pill. Clinical trials involving 755 US women confirmed that Levlite provides high contraceptive efficacy with good cycle control. Headache, reported by 17.3% of study participants, was the most common side effect.
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PMID:Berlex introduces new 20 mcg birth control pill. 1229 11

This article is about the decision made by Wyeth-Ayerst to settle lawsuit claims filed by more than 36,000 American women concerning the use of the Norplant contraceptive implant system. The settlement, estimated at $50 million, would end 5 years of litigation involving Norplant. The plaintiff's lawyers claimed that the company downplayed such side effects as irregular menstrual bleeding, nausea, headaches, and depression. Wyeth-Ayerst Laboratories and parent company American Home Products Corp. have denied any wrongdoing and claimed that the side effects were described in the product label. The agreement to settle the Norplant claims were described as purely a business decision by Wyeth-Ayerst North America president Joseph Mahady.
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PMID:Manufacturer moves to settle Norplant claims. 1229 28

Preliminary results of side effects are reported by 66 physicians of the M.F.P.F. (Mouvement Francais de Planning Familial) on 2026 women taking Stediril, 610 taking Aconcept, and 824 taking Ov 28 for at least 6 months (less for dropouts) since 1969. There were no pregnancies or severe complications except 1 case of jaundice and 2 of thrombosed hemorrhoids. Blood pressure was unchanged in 60-70% of cases, and the graph of these changes, except for a slight increase at "up to 10 mm Hg," was a symmetrical bell curve. Stediril and Ov 28 had identical effects on blood pressure, but the curve for Aconcept was flatter. Weight gain of 1 kg or more was reported in 37% of Stediril users and 42% of Ov 28 users (p less than .05). Other side effects showing significant differences between products were: nausea greater with Ov 28, depression greater with Aconcept, metrorragia greater with Stediril, pelvic pain less with Stediril, headaches less with Ov 28, amenorrhea less with Stediril. This absence of serious side effects was considered the most significant French statisitc published to date on oral contraceptives.
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PMID:[Statistical study of side effects in 3460 women taking combined estrogen-progestagens: preliminary results]. 1230 13

A clinical trial was carried out on the levonorgestrel-containing subdermal contraceptive implant to evaluate its efficacy and acceptability among Malaysian women. The study recruited 121 women in and around the Kuala Lumpur Federal Territory over a 13-month period (March 1986-March 19870 and followed regularly for 2 years at intervals of 3, 6, 12, and 24 months. The acceptors consisted of 53.7% Malays, 24.8% Indians, and 21.5% Chinese. 81% of the selected females were between 20-34 years in age (mean=30). The average parity was 3.9 children; 81.8% reported that they did not want to have a child in the he next 3 years. In the last 6 months, 45.5% of the study group had used the oral contraceptive pills, 15.7% had used the intrauterine contraceptive device, and 17.4% had not employed any method. The results showed that the subdermal implant Norplant (R) is effective and safe. The gross cumulative continuation rate was 93.8 at 6 months, 88.2 at 12 months, and 72.2 at 24 months. Within the 24 month period, 26 terminations occurred as a result of pregnancy (n=1), menstrual problems (n=9), medical reasons (n=12), and personal reasons (n=4). the gross cumulative termination rate/100 women for pregnancy was 0 at 12 months and 1.7 at 24 months. Major side effects include menstrual problems, weight gain, dizziness, and headache. After 1 year, 13.3% of the cases (n=2) had the implant removed. The acceptability of the method among our women in 4 clinics around Kuala Lumpur and other Norplant (R) studies in other countries is comparable to the intrauterine devices among Malaysian women; the termination rate for accidental pregnancy is lower than that of IUD. The device is easy to administer in a small clinical set-up though it requires personnel specially trained in the surgical techniques; 86.0% of the acceptors reported complication-free insertion. This may be a method to be introduced to our National Family Planning Program in our efforts to offer a wider range of safe and effective methods of family planning. (author's modified).
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PMID:A study of the acceptability and effectiveness of Norplant (R) contraceptive implants in Kuala Lumpur, Malaysia. 1231 41


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