Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs
NCT ID: NCT02479256
Last Updated: 2016-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
600 participants
INTERVENTIONAL
2015-06-30
2016-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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), 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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 25 and 30 Kg/m 2.
* Polycystic ovary syndrome (using ESHRE/ASRM criteria).
Exclusion Criteria
* Patients with BMI under 25 or over 30 Kg/m 2.
* Hyper or hypothyroidism, or hyperprolactinemia.
* Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs.
* Intention to start a diet or a specific program of physical activity.
* Organic pelvic diseases.
* Tubal or male factor infertility.
* Interval of earlier treatment with any of the fertility drugs of less than 6 months.
* Contraindication to either:
* Clomiphene citrate.
* Tamoxifen.
* HCG injection.
FEMALE
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Mohamed S Sweed, MD
Lecturer
Principal Investigators
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Gasser M. El-Bishry, FRCOG
Role: STUDY_DIRECTOR
Professor of Obstetrics and Gynaecology, Ain Shams University
Abdel-Latif G. El-Kholy, MD
Role: PRINCIPAL_INVESTIGATOR
Assistant professor of Obstetrics and Gynaecology, Ain Shams University
Mohamed S. Sweed, MD
Role: PRINCIPAL_INVESTIGATOR
Lecturer of Obstetrics and Gynaecology, Ain Shams University
Diana N. Kolta, MB BCh
Role: PRINCIPAL_INVESTIGATOR
Resident of Obstetrics and Gynaecology
Locations
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Ain Shams University Maternity Hospital
Cairo, , Egypt
Countries
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Other Identifiers
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20092009
Identifier Type: -
Identifier Source: org_study_id
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