Ovulation Inhibition
Conditions
Keywords
quick starting contraception
Brief summary
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.
Detailed description
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.
Interventions
DRUGZoely
quick start of combined hormonal contraception containing 1.5 mg estradiol /2.5 mg nomegestrol acetate
DRUGMeliane ED
quick start of combined hormonal contraception containing 20 mcg ethinyl estradiol /75 mcg gestodene
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
two intervention groups
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy women, age 18 - 40 years * prior normal and regular interval of menstruation
Exclusion criteria
* current breast feeding women * within 1 month period of child-delivery or miscarriage * body mass index 30 kg/m2 or more * contraindicated to use combined hormonal contraception * current using other hormonal drugs that affect ovulation function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ovulation inhibition | 1 month | comparison of ovulation inhibition effect between Zoely and Meliane ED with mid follicular phase starting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| follicular development | through study completion, an average of 1 month | pattern of ovarian follicular change after receive intervention |
Countries
Thailand
Outcome results
None listed