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Some scientists added the progestin levonorgestrel to the vaginal ring which must be removed every 3 weeks to address the problem of irregular bleeding, but it adversely altered lipoprotein levels and caused too many hemorrhaging problems. On the other hand, scientists in the laboratory at Organon have conducted various studies of a vaginal ring with ethinyl estradiol and 3-keto-desogestrel at different doses which have yielded favorable results. A multicenter European study was conducted with 400 women aged 18-40 years wearing a vaginal ring with 0.120 mg keto-desogestrel and 0.015 mg ethinyl estradiol every day for 9 months. 10% had slight bleeding 15 days after insertion of the vaginal ring. In 10 women tested, the plasmal levels of progesterone and estrogen decreased by 4 nmol/l and 0.010 nmol/l, respectively. The first French study was conducted at the Gynecology College of Bordeaux and the South-West in 1988 and included 40 women followed for 9 cycles. The vaginal ring consisted of 2 compartments: the biggest compartment contained only 3-keto-desogestrel and the other also contained ethinyl estradiol. It remained in the vagina for 21 days, then was removed to be rinsed, dried, and placed in a box. It was reinserted on the 5th or 7th day of the cycle. This ring reduces the volume of blood during menses and eliminates abdominal cramps, nausea, and headaches. Women tolerate the vaginal ring better than they do oral contraceptives (OCs); for example, it does not cause them to gain weight, they tolerate glucose well, it brings about favorable changes in lipoproteins, it does not bring about conditions favorable to thrombophlebitis, and it can improve the skin for acne-sufferers. Young women accept vaginal rings enthusiastically. The efficacy of vaginal rings with 2 steroids is the same as that of OCs.
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PMID:[Vaginal contraception with steroids]. 1228

The injectable contraceptive depot-medroxyprogesterone acetate (DMPA) dissolves slowly and is released over 3 months to suppress ovulation. It is more than 99% effective at preventing pregnancy. More than 30 million women in 90 countries have used DMPA and none have died from using it. A World Health Organization [WHO] study showed that DMPA did not significantly increase the risk of breast cancer or other cancers. One study points to a small reduction in bone density with DMPA use, but the reduction did not become larger with long-term use and may even be reversible. The US Food and Drug Administration (FDA) thoroughly reviewed these studies and the experiences of DMPA users. This review resulted in the FDA's approving DMPA as a contraceptive in October, 1992. Almost all DMPA users experience menstrual changes with irregular bleeding and spotting occurring during the 1st few months. After 12 months, at least 50% of DMPA users experience amenorrhea, which some women consider a benefit. Other possible but rare side effects are weight gain, headache, breast tenderness, loss of libido, depression, nervousness, and fatigue. It takes longer for past DMPA users to conceive after stopping DMPA use than users of other contraceptive methods, but by 18 months more than 90% of past DMPA users who wanted to become pregnant conceived. DMPA does not protect users from sexually transmitted diseases (STDs) or HIV/AIDS. They need to use latex condoms to prevent STD/HIV transmission. DMPA users must return to their health care provider every 3 months for another injection. DMPA is a viable contraceptive for women wanting a safe, reliable, long-term, reversible contraceptive. Any woman wanting to use DMPA should discuss it with her provider.
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PMID:Facts about injectable contraception. 1228 37

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

The Norplant System of levonorgestrel implants and the Depo Provera contraceptive Injection of sterile medroxy progesterone acetate suspension (DMPA) are longterm, progestagen-based contraceptive delivery systems designed to overcome noncompliance which are under review for use in Canada. 150 mg of DMPA, a pregnane compound derived from progesterone, is injected every 3 months. Peak plasma concentrations are reached in 24 hours and plateau for 3-4 months before gradually declining. After termination, ovulation returns on average in 4.5 months, and conception occurs at a median time of 10 months. 90% conceive by 24 months. In the Norplant system, a steady daily supply of 50-80 mcg of levonorgestrel, a gonane progestin derived from the testosterone nucleus which has both progestogenic and androgenic receptor affinity, diffuses from 5 Silastic implants, which must be replaced every 5 years. Ovulation and fertility return rapidly after rod removal. The actual and lowest expected failure rates are equal for both systems. The failure rate for DMPA is .3 pregnancies per 100 women years, while that for levonorgestrel is .4% in 1 year. Although neither method affects blood pressure, DMPA appears to affect carbohydrate metabolism by impairing glucose tolerance and increasing insulin production. Lipid metabolism is also affected. 5% of those who use levonorgestrel discontinue it because of side effects, including headache, mastodynia, and acne; 19.1% of DMPA users did so, especially for weight gain and menstrual cycle abnormalities. Both methods have a higher frequency of menstrual abnormalities than normal. 27.7% of levonorgestrel users experienced prolonged bleeding, while 17% experienced spotting during the first 6 months. However, normal menses usually returned within a year, and only 7.9% discontinued use because of cycle abnormalities. In 1 study, less than 10% of DMPA users experienced normal cycles, and in another study 35% experienced amenorrhea (500/700 discontinued use). Amenorrhea replaced irregular bleeding with continued use, occurring in 68% of users by 2 years. There is also some concern about DMPA and breast cancer and bone loss. Based on 1 case-control study of 110 women with breast cancer who had taken DMPA, the relative risk is highest for those between ages 25 and 34 who use DMPA longer than 6 years. A WHO study concluded that the relative risk of developing breast cancer, because of DMPA, is inversely related to duration of use. A Phase IV study on DMPA and bone mineral density has been undertaken.
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PMID:A comparison of levonorgestrel implants with depo-medroxyprogesterone acetate injections for contraception. 1231 30

Marvelon, a monophasic oral contraceptive (OC) containing 30 mcg of ethinyl estradiol and 150 mcg of desogestrel, has been available to Malaysian women through the national family planning program since 1982. To assess the safety, effectiveness, and side effects associated with this OC, 247 women who requested the pill were enrolled in a multicenter prospective study that included follow-up after the first, third, and sixth cycles of use. 81% of participants had never used any form of contraception before Marvelon. 194 women (79%) completed the 6-month study. There were no pregnancies recorded. Although women reported a slightly increased incidence of nausea, breast tenderness, and headache in the first treatment cycle, these side effects had abated by the end of the third cycle. After six cycles, mean body weight had decreased by an average of 0.4 kg. Both systolic and diastolic blood pressure were unaffected. An unexpected finding was a decrease in the severity of acne with continuous use of Marvelon. Although both spotting and breakthrough bleeding increased slightly in the first two cycles, irregular bleeding returned to pretreatment levels by the third cycle. The length of the withdrawal bleed in the pill-free week was reduced. The incidence of irregular bleeding and other side effects was substantially lower in this sample of Malaysian women than in Asian and Caucasian Marvelon users surveyed in other studies.
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PMID:A prospective study of a monophasic oral contraceptive containing 30 mcg ethinyl oestradiol and 150 mcg desogestrel (Marvelon). 1232 Mar 38

The results of the 1998 "Contraceptive Technology Update" Pill Survey indicate that Norplant implants continue to lag on providers list of family planning (FP) choices. 67% of US FP providers who responded to the survey reported no Norplant insertions in the year preceding the survey. For the 18.1% who inserted 1 to 5 implants, 11.7% removed the same number. The number of removals outranked insertions in the 3 subsequent insertion ranges. Headaches, irregular bleeding, and the end of the 5-year use period were among the major causes of method termination. Research on Norplant has indicated that method continuation is substantially enhanced when the acceptor is a mature woman with a long-term interest in contraception, has been counseled about potential side effects, and is able to accept these side effects. Partner attitudes toward Norplant are another important determinant of satisfaction.
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PMID:Norplant: overcoming barriers to method use. 1232 44

This study presents findings on the socio-demographic and health characteristics, continuation rates, menstrual disturbances, and changes in menstrual patterns as well as other side effects among a sample of 952 1st time acceptors of the injectable contraceptive Depo-Provera during 1978-1980 in Colombo, Sri Lanka. Those continuing to use the method were observed for 24 months. The reasons for discontinuation are discussed based on another study that focused on 321 discontinuers who received Depo-Provera from the same clinic. The overall continuation rates at 12 and 24 months were 58% and 29%, respectively. Relatively older and higher parity women had lower continuation rates than younger and lower parity women. The occurrence of amenorrhea rose sharply foloowing the 1st dose and stabilized such that about 1/3 of those continuing with Depo-Provera became amenorrheic. 1/4 of the women experienced menstrual disturbances such as spotting and irregular bleeding. Other side effects, including vomiting, headache, and dizziness, affected 6% of the women following the 1st dose, but declined gradually over time. Over the course of the observation, 41-66% of the women appeared to gain weight. The 2 primary reasons for discontinuing Depo-Provera were non-medical: 1) the desire to have another child and 2) the decision to be sterilized. The findings suggest that Depo-Provera has played a signinficant role in Sri Lanka in 2 ways: 1) its use has provided desired pregnancy spacing for those who wished to have another child and 2) it has assisted couples by providing them with time (without the fear of pregnancy) to decide to stop having children and then get sterilized.
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PMID:Depo-Provera use in Sri Lanka: acceptor characteristics, continuation and side effects. 1234 Nov 88

Family planners responding to an annual oral contraceptives (OC) survey tended to recommend switching pills for complaints of headaches and mood swings and life style changes for the complaint of weight gain. Nearly 3/4 of survey respondents indicated that headaches and mood swings affected less than 5% of their patients. On the other hand, 29% reported that less than 5% of patients complained of weight gain; 27% said 10% complained; 19% said 10-15% complained; 10% said 15 to 20% complained; and 14% said more than 20% of patients complained of weight gain. 57% of the 137 respondents would instruct patients to exercise more and reduce calorie intake, and only 13% would change a patient's pill formulation because of weight gain. Nausea, breast changes, breakthrough bleeding, and compliance issues seem to be more relevant to birth control pills. However, a study indicated that women who discontinue more often do it because more often do it because of weight gain or acne than because of irregular bleeding or amenorrhea. Some women have gained 10-30 lbs using OCs. Researchers in Sweden recorded the secretion of the satiety hormone cholecystokinin during a 24-hour period before and during administration of OCs to 9 women, and found that pills suppressed the serum profiles of cholecystokinin inducing the feeling of hunger. Further studies are needed to evaluate the mechanism of this effect.
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PMID:Lifestyle changes most often suggested for weight complaints. Special report: annual pill survey. 1234 23

A postmarketing observational study was carried out in a prospective, open and multi-centric manner monitoring a treatment period of 4 cycles (4 x 28 days) among Indian women of child bearing age to determine the acceptability and reliability of desogestrel (75 microg/day), an oestrogen-free pill. It involved 299 subjects recruited at each of 20 centres spread all over India. The study duration for each subject was 16 weeks with follow-up visits at 4, 8 and 16 weeks intervals. At each follow-up visit, subjects were evaluated for any failure of contraception, change in bleeding pattern and other adverse events. Of the study subjects, 238 (79.6%) continued the study for 4 cycles and were thus considered eligible for analysis of bleeding patterns with no failure of contraception. In addition, the physician's as well as patient's global assessment, demonstrated a "very good" response in majority of subjects (> 84%). A sizeable number of cases (47.9%) had infrequent episodes (1 to 5) of bleeding--spotting during the shifted reference period, while 41.2% experienced amenorrhoea. There was no clinically significant change in blood pressure or body weight. Of the 299 such subjects enrolled, 53 subjects were lost to follow-up and did not come for the 1st follow-up visit. Hence, out of the 246 subjects, 21.1% presented with 78 separate adverse events during 960 treatment cycles. None of the reported adverse events were severe and there was not even a single serious adverse effect during the course of the study. Nausea, breast tenderness and headache (7.7%, 10.1% and 9.7% respectively) were the most frequent adverse events observed during the study. Desogestrel 75 mg/day was well accepted in majority of Indian women. It provides good contraceptive efficacy, with a lower incidence of irregular bleeding and spotting episodes.
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PMID:A postmarketing observational study assessing acceptability and reliability of desogestrel only contrapceptive pill (Cerazette) in Indian women. 1744 70

(1) Intrauterine devices (IUDs) are placed in the uterine cavity with the objective of providing long-term contraception, mainly by preventing fertilisation. The best-known IUDs contain copper, but there is also an IUD delivering levonorgestrel, a progestin; (2) How effective are these devices, and what are their adverse effects? To answer these questions, we analysed the literature using the standard Prescrire methodology; (3) T-shaped copper IUDs, with a copper surface area of 380 mm2 on 3 arms, and the levonorgestrel-releasing device, have similar contraceptive efficacy as combined oral contraceptives that are used correctly. In contrast, IUDs are more effective than oral contraception used incorrectly; (4) Among IUD users, there are on average about 6 pregnancies per 1000 woman-years. There is less experience with the levonorgestrel IUD which seems to be at least as effective as copper IUDs; (5) The rare intrauterine pregnancies that occur in women using an IUD generally end in miscarriage. About 25% of these pregnancies end in a live birth if the device is left in place, compared to about 90% if the device is removed; (6) Ectopic pregnancies are rarer in IUD users than in women who do not use contraception. However, about one in 20 pregnancies that occur in women using an IUD is ectopic; (7) The IUD is expelled in about 5% to 10% of cases within 5 years, and expulsion recurs in about 30% of these women; (8) Problems such as difficult insertion, pain, bleeding and syncope are reported in less than 1.5% of cases overall; (9) Uterine perforation during insertion is rare, occurring in 0.6 to 16 cases per 1000 insertions, regardless of the type of IUD. The risk of perforation is higher when the IUD is inserted less than 4 to 6 weeks after delivery or elective abortion; (10) During the first 3 months after insertion, the risk of pelvic infection is slightly higher than in the general population, especially in women with pre-existing asymptomatic Chlamydia trachomatis infection. There are about 6 pelvic infections per 1000 woman-years of IUD use. Routine antibiotic prophylaxis is unnecessary. The interview and physical examination may lead to diagnosis of C. trachomatis infection or other sexually transmitted infections. In these cases, treatment may be needed before IUD insertion. Women must be warned that IUDs do not protect them from sexually transmitted diseases; (11) Menstrual bleeding is often heavier in women with cooper IUDs than in women who do not use IUDs, and may be associated with menstrual pain; (12) The levonorgestrel IUD is associated with a marked reduction in menstrual blood loss and irregular bleeding; amenorrhoea occurs in 35% of women after 2 years of use. The levonorgestrel IUD also has hormonal adverse effects such as headache, acne, breast tension and functional ovarian cysts; (13) IUDs can safely be used in breastfeeding women, immediately after a pregnancy, in cases of diabetes or HIV infection, during nonsteroidal antiinflammatory drug therapy, and after an ectopic pregnancy. The only problems occurring in women who have never had children are pain during insertion and more frequent expulsions; (14) A copper IUD is a first-line contraceptive method for women with a history of deep venous thrombosis, pulmonary embolism, or coronary events; (15) It is better to postpone IUD insertion when the woman has a genital tract infection or unexplained vaginal bleeding; (16) IUD insertion is an effective alternative to "morning-after" hormonal contraception.
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PMID:Intrauterine devices: an effective alternative to oral hormonal contraception. 1963 36


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