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  • Title: Multicenter trial of two monophasic oral contraceptives containing 30 mcg ethinylestradiol and either desogestrel or gestodene in Thai women.
    Author: Koetsawang S, Charoenvisal C, Banharnsupawat L, Singhakovin S, Kaewsuk O, Punnahitanont S.
    Journal: Contraception; 1995 Apr; 51(4):225-9. PubMed ID: 7796587.
    Abstract:
    The efficacy and acceptability of two third generation oral contraceptives in Thai women were evaluated in a prospective, open, group-comparative, randomized, multicenter trial of women asking for contraception. In six Family Planning Centers and Outpatient Gynaecological Clinics in urban areas in Thailand, 783 healthy women who were at risk for pregnancy and did not have contraindications to oral contraceptive use were randomly allocated to one of the two study groups. An oral contraceptive containing 30 mcg ethinylestradiol and 150 mcg desogestrel was given to 394 women and an oral contraceptive with the same amount of ethinylestradiol and 75 mcg gestodene to 389 women during 6 cycles. Criteria of cycle control, side effects and the presence and severity of acne vulgaris were assessed and blood pressure and body weight measured at pretreatment and after cycles 1, 3 and 6. Furthermore, the efficacy was evaluated after the last cycle. No pregnancies occurred with either of the contraceptives. The incidences of irregular bleeding and minor side effects in both groups were very low and decreased after an initial increase in the first cycle. Acne improved in both groups. Blood pressure and body weight remained unchanged. The two oral contraceptives were found to be effective and acceptable in Thai women. Compared to Caucasian women, the incidences of irregular bleeding and side effects were apparently lower in these Asian women. Furthermore, the effects of both oral contraceptives were comparable. During October 1988-April 1990, clinicians randomly allocated 783 healthy women attending six family planning centers and outpatient gynecological clinics in urban areas of Thailand to either the group using a 30 mcg ethinyl estradiol (EE) combined oral contraceptive (OC) with 150 mcg desogestrel (DSG) (394 women) or an OC with 75 mcg gestodene (GSD) (389 women). Researchers aimed to evaluate the efficacy and acceptability of these two third-generation OCs. After six cycles of OC use, the continuation rate was 87.6% for DSG/EE and 85.9% for GSD/EE. No one from either group became pregnant. Women forgot to take the pills during 1.8% of the cycles with DSG/EE and 2% of the cycles with GSD/EE. Breakthrough bleeding was more common than spotting in both groups (0.8-5.4% vs. 0.6-2% for DSG/EE; 0.8-4.4% vs. 0-4.4% for GSD/EE), while in Caucasian women spotting was more common. Breakthrough bleeding and spotting rates were comparable in both groups. Irregular bleeding initially increased, then fell with time. Irregular bleeding for both OC groups was less common than it is in Northern European women. No one experienced any serious side effects. The most common minor side effects were nausea, headache, and breast tenderness. The incidences increased in the first cycle, then fell. They were comparable for both groups. Acne was less frequent after OC use (20.7% at baseline vs. 17.1% at 6 months for DSG/EE and 22% at baseline vs. 16.9% at 6 months for GSD/EE). Neither OC influenced the mean body weight or the mean blood pressure. These findings indicated that both OCs are very effective, provide excellent cycle control, and produce a low incidence of side effects. They also protect against acne.
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