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Quick starting combined oral contraception containing estradiol hemihydrate/nomegestrol acetate is effective to inhibit ovulation in healthy reproductive age women and non-inferiority to combined oral contraception containing ethinyl estradiol/gestodene.
This study is a randomized control, non-inferiority trial which compare the proportion of ovulation between two oral combined pills when delay starting the first tablet at mid-follicular phase of menstrual cycle in 18 - 40 year old, healthy women with prior normal and regular periods. Participations will be undergone trans-vaginal or trans-rectal ultrasonography between day 1 - 3 of menstrual period for evaluation of ovarian follicle/cyst (if present). Only women who have normal looking of ovaries without dominant ovarian follicle will be included in study-protocol. Immediately after trans-vaginal/trans-rectal ultrasound between day 7 - 9 of menstrual period, all participants will be randomly assigned to receive one pack of investigated pills (1.5 mg estradiol hemihydrate/2.5 mg nomegestrol acetate or 20 mcg ethinyl estradiol/75 mcg gestodene) and to take the first tablet under direct observation by research-nurse. Participants will take one consecutive tablet at about the same time each day until complete pack. The next appointments will be every 2 - 3 days to monitor ovarian function by using Hoogland score until ovulation or follicular quiescence will be presented. The last visit will be about 1 week after complete pack to monitor adverse effect and safety through out the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meliane ED | Active Comparator | 20 mcg ethinyl estradiol/70 mcg gestodene |
|
| Zoely | Experimental | 1.5 mg estradiol/2.5 mg nomegestrol acetate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoely | Drug | quick start of combined hormonal contraception containing 1.5 mg estradiol /2.5 mg nomegestrol acetate |
|
| Measure | Description | Time Frame |
|---|---|---|
| ovulation inhibition | comparison of ovulation inhibition effect between Zoely and Meliane ED with mid follicular phase starting | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| follicular development | pattern of ovarian follicular change after receive intervention | through study completion, an average of 1 month |
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Inclusion Criteria:
Exclusion Criteria:
female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Bangkok Noi | Bangkok | 10700 | Thailand |
Undecided
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two intervention groups
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| Meliane ED | Drug | quick start of combined hormonal contraception containing 20 mcg ethinyl estradiol /75 mcg gestodene |
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