PCOS Clinical Trial
Official title:
Clomiphene Citrate Versus Tamoxifen for Induction of Ovulation in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial
Comparison between Clomiphene citrate and Tamoxifen for induction of ovulation in women with PCOS.
Participants fulfilling inclusion and exclusion criteria will be divided into two groups,
each group containing 300 participants;
Group (A):
300 participants will receive Clomiphene citrate oral tablets and placebo of Tamoxifen oral
tablets.
Group (B):
300 participants will receive Tamoxifen oral tablets and placebo of Clomiphene oral tablets.
Participants with abnormal menstrual history will receive two tablets of norethisterone 5mg
tab (Steronate nor ®, hi pharm/Egypt) every12 hours for 5 days to withdraw period before
starting the procedure.
Then;
Group (A):
Women will receive one tablet of clomiphene citrate oral tablets 50 mg (Clomid®,
aventis/Egypt) twice daily 12 hours apart (total dose 100 mg daily), and one tablet of
placebo of tamoxifen oral tablets twice daily 12 hours apart from the 3rd day of the menses
for 5 days, for only one menstrual cycle.
Group (B):
Women will receive one tablet of tamoxifen oral tablets 10 mg (Tamoxifen®, amriya/Egypt)
twice daily 12 hours apart (total dose 20 mg daily), and one tablet of placebo of clomiphene
citrate twice daily 12 hours apart from 3rd day of the menses for 5 days, for only one
menstrual cycle.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
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