Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-06 @ 12:25 AM
Study NCT ID:
NCT02479256
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2015-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Clomiphene Citrate Versus Tamoxifen for Induction of Ovulation in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: