NCT02479256

Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs

Clomiphene Citrate Versus Tamoxifen for Induction of Ovulation in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

Comparison between Clomiphene citrate and Tamoxifen for induction of ovulation in women with PCOS.

Detailed description

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.

Conditions

• PCOS

Interventions

Type	Name	Description
DRUG	Clomiphene citrate	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) from the 3rd day of the menses for 5 days, for only one menstrual cycle.
DRUG	Tamoxifen Placebo	Women will receive 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.
DRUG	Tamoxifen	Women will receive one tablet of tamoxifen oral tablets 10 mg (Tamoxifen®, amriya/Egypt) twice daily 12 hours apart (total dose 20 mg daily) from 3rd day of the menses for 5 days, for only one menstrual cycle.
DRUG	Clomiphene citrate placebo	Women will receive 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.

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-06-24
• Last updated: 2016-05-17

Locations

1 site across 1 country: Egypt