PCOSPhase 4NCT02479256
Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs
A Phase 4 study testing Clomiphene citrate and Tamoxifen in people with PCOS, run by Ain Shams University at 1 site in Egypt.
Trial summary
Comparison between Clomiphene citrate and Tamoxifen for induction of ovulation in women with PCOS. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS
- What is being tested?
- Clomiphene citrate and Tamoxifen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2015to May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primary infertility.
- Body mass index (BMI) between 25 and 30 Kg/m 2.
- Polycystic ovary syndrome (using ESHRE/ASRM criteria).
Who cannot join
- Secondary infertility.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene citrateDrug
Also called Clomid
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 PlaceboDrug
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.
TamoxifenDrug
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 placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene citrate + placebo | Experimental | 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. Receives: Drug: Clomiphene citrate; Drug: Tamoxifen Placebo |
| Tamoxifen + placebo | Experimental | 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. Receives: Drug: Tamoxifen; Drug: Clomiphene citrate placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ovulation.
- Transvaginal ultrasound done to:
- 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:
- Level 6 ng/ml or 19 nmol/L indicates Ovulation.
- Level <5 nmol/L suggests Ovulation did not occur.
Measured: Up to 4 weeks from starting treatment.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: Up to 4 weeks from starting treatment.
Pregnancy rate both clinical and biochemical.
Transvaginal ultrasound done to:
- 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.
- Detect gestational and fetal pulsation.
Measured: Up to 8 weeks from starting treatment.
Patient compliance.
Asking the participant about the empty strips.
Measured: 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.
Measured: Up to 4 weeks from starting treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
- Investigators
- Gasser M. El-Bishry, FRCOG, Study director, Professor of Obstetrics and Gynaecology, Ain Shams UniversityAbdel-Latif G. El-Kholy, MD, Principal investigator, Assistant professor of Obstetrics and Gynaecology, Ain Shams UniversityMohamed S. Sweed, MD, Principal investigator, Lecturer of Obstetrics and Gynaecology, Ain Shams UniversityDiana N. Kolta, MB BCh, Principal investigator, Resident of Obstetrics and Gynaecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479256
- Sponsor's protocol ID
- 20092009
- Status last verified
- May 2016
- First submitted
- 13 Apr 2015
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clomiphene Citrate Versus Tamoxifen for Induction of Ovulation in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02479256
- Acronym / sponsor ID
- 20092009
- Conditions
- PCOS
- Keywords
- PCOS, Induction of ovulation, Clomiphene citrate, Tamoxifen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomiphene citrate + placebo | Experimental | Drug: Clomiphene citrate, Drug: Tamoxifen PlaceboWomen 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. |
| Tamoxifen + placebo | Experimental | Drug: Tamoxifen, Drug: Clomiphene citrate placeboWomen 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Primary infertility.
- Body mass index (BMI) between 25 and 30 Kg/m 2.
- Polycystic ovary syndrome (using ESHRE/ASRM criteria).
Key exclusion criteria (12 listed)
- Secondary infertility.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clomiphene citrateAlso: ClomidWomen 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 | Clomiphene citrate + placebo |
| Tamoxifen PlaceboWomen 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 | Clomiphene citrate + placebo |
| TamoxifenWomen 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 | Tamoxifen + placebo |
| Clomiphene citrate placeboWomen 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. | Drug | Tamoxifen + placebo |
Primary outcome
Rate of ovulation.
Time frame: Up to 4 weeks from starting treatment.
* 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.
6 secondary outcomes
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.
Time frame: Up to 4 weeks from starting treatment.
Endometrial thickness and quality in the pre-ovulatory period.
Time frame: Up to 4 weeks from starting treatment.
Number of growing follicles detected by transvaginal ultrasound.
Time frame: Up to 4 weeks from starting treatment.
Pregnancy rate both clinical and biochemical.
Time frame: Up to 8 weeks from starting treatment.
Patient compliance.
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.
Time frame: Up to 4 weeks from starting treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gasser M. El-Bishry, FRCOG study director
Professor of Obstetrics and Gynaecology, Ain Shams University
Abdel-Latif G. El-Kholy, MD principal investigator
Assistant professor of Obstetrics and Gynaecology, Ain Shams University
Mohamed S. Sweed, MD principal investigator
Lecturer of Obstetrics and Gynaecology, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clomiphene citrate and Tamoxifen in people with PCOS, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ovulation. (time frame: Up to 4 weeks from starting treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.