A Phase 4 interventional study of Clomiphene citrate and Tamoxifen Placebo in PCOS, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-17.
Sponsored by Ain Shams University · Phase 4, Interventional, and Supportive care
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.
Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Contraindication to either:
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.
Drug: Clomiphene citrate · Drug: Tamoxifen Placebo
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.
Drug: Tamoxifen · Drug: Clomiphene citrate placebo
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.
Also known as: Clomid
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.
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.
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.
Rate of ovulation.
* Transvaginal ultrasound done to: 1\. Detect signs of ovulation: corpus luteum, fluid in cul-de-sac, collapse of the follicle size. * Serum progesterone will be measured in the mid luteal day of the cycle, where: 1. Level 6 ng/ml or 19 nmol/L indicates Ovulation. 2. Level \<5 nmol/L suggests Ovulation did not occur.
Time frame: Up to 4 weeks from starting treatment.
Endometrial perfusion by using 3D- power Doppler (GE Medical system volouson E6, 5-7 MHz) in the mid luteal day of the cycle to assess endometrial receptivity.
Endometrial perfusion by using 3D-power Doppler (GE Medical system volouson E6, 5-7 MHz) at Ain-Shams University Maternity Hospital will be done in the mid luteal day of the menstrual cycle to assess endometrial receptivity by measured: * Gray: mean Gray value. * Color angio: Flow index, Vascularization index, and Vascularization flow Index.
Time frame: Up to 4 weeks from starting treatment.
Endometrial thickness and quality in the pre-ovulatory period.
Transvaginal ultrasound will be done to: Evaluate endometrial thickness and quality pre-ovulatory: where the minimal endometrial thickness to achieve a pregnancy ranges from 4 to 7mm with a healthy trilaminar appearance.
Time frame: Up to 4 weeks from starting treatment.
Number of growing follicles detected by transvaginal ultrasound.
Transvaginal ultrasound will be done to: Detect mean follicular diameter in the days 10, 12, 14 and up to day 25 of the cycle.
Time frame: Up to 4 weeks from starting treatment.
Pregnancy rate both clinical and biochemical.
Transvaginal ultrasound done to: 1. Evaluate endometrial thickness and quality in the mid luteal day of the cycle: where the optimal endometrial thickness to achieve a pregnancy ranging from 10 to 15mm with a healthy trilaminar appearance. 2. Detect gestational and fetal pulsation.
Time frame: Up to 8 weeks from starting treatment.
Patient compliance.
Asking the participant about the empty strips.
Time frame: Up to 4 weeks from starting treatment.
Adverse effects: such as headache, nausea, vomiting, breast tenderness, blurred vision, and ovarian enlargement or hyperstimulation.
Asking the participant if there are any complaints about the side effects of the drugs.
Time frame: Up to 4 weeks from starting treatment.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Clomiphene · Tamoxifen