Family Unit, King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
NCT Number: NCT01482338
The purpose of this study is to determine whether low-dose combine oral contraceptives (COC) containing desogestrel 150 mg and drospirenone 3 mg are effective in the treatment of Premenstrual symptoms.
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Notify Me18 year–35 year
Female
Interventional
Phase 4
Bangkok, 10330, Thailand
Premenstrual syndrome is commonly reported 20-90 percent in reproductive-aged women. Only a small percentage of women (2 to 5%) have significant premenstrual symptoms defined as Premenstrual dysphoric disorder (PMDD). The exact symptoms and their intensity vary from woman to woman and even from cycle to cycle.While exact causes of PMS are not fully understood,current thinking suspects that fluctuation of endogenous sex hormones are relevant. The standard 21/7 design may induce menstrual-related symptoms including headache, mood swings, abdominal cramping, bloating, and breast tenderness that increase during the last week of active pills extending along the 7-day hormone free interval(HFI). The decline in endogenous estradiol levels during HFI may be responsible for the estrogen-withdrawal symptoms. While a new COC with drospirenone introduced in 24/4 design has been shown in clinical trials to significantly improve the symptoms of PMS, there has been questioned about efficacy of the other kind of COC which has optimal properties, for example, good-control cycles extend to the similar 24/4 regimen.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comparison of 2 different low-dose oral contraceptive pill which one consists of 20 microgram ethinyl estradiol and 150 mg desogestrel and the other consists of 20 microgram ethinyl estradiol and 3 mg drospirenone. Both were taken orally by participants every day beginning Day1 to Day 3 of the first menstrual cycle until complete 24 days and continued with free-hormone pills for 4 days. The next cycle has to continue in the same way until complete 6 cycles.
Other names: Mercilon
Comparison of 2 different low-dose oral contraceptive pill which one consists of 20 microgram ethinyl estradiol and 150 mg desogestrel and the other consists of 20 microgram ethinyl estradiol and 3 mg drospirenone. Both were taken orally by participants every day beginning Day1 to Day 3 of the first menstrual cycle until complete 24 days and continued with free-hormone pills for 4 days. The next cycle has to continue in the same way until complete 6 cycles.
Other names: Yaz
Time frame: 8 months
Chulalongkorn University
Other
A Comparative Efficacy of Low-dose Combine Oral Contraceptives Containing Desogestrel 150 mg and Drospirenone 3 mg on Premenstrual Symptoms
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