Polycystic Ovary SyndromeNCT00911313
Letrozole or Combined Metformin Clomiphene Citrate (CC) for Women With CC Resistant Polycystic Ovary Syndrome
A study testing Letrozole tablets (Femara; Novartis Pharma, Switzerland), metformin HCl (Cidophage®; CID,Cairo, Egypt) and CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) in people with Polycystic Ovary Syndrome, run by Mansoura University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone. Read more about this study
- Who is it for?
- Ages 20 to 36 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Letrozole tablets (Femara; Novartis Pharma, Switzerland), metformin HCl (Cidophage®; CID,Cairo, Egypt) and CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2006to Jan 2009
- Phase
- Interventional
- 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 20 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- CC resistant PCOS
Who cannot join
- Congenital adrenal hyperplasia
- Cushing syndrome
- Androgen secreting tumors
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospitals,OB/GYN department
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Letrozole Versus Combined Metformin and Clomiphene Citrate for Ovulation Induction in Clomiphene-Resistant Women With Polycystic Ovary Syndrome
The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.
Read the detailed description
Withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation. In the letrozole group, 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days, whereas all patients in the combined metformin-CC group) received metformin HCl [Cidophage®; Chemical Industries Development(CID), Cairo, Egypt], 500 mg three times daily for 6-8 weeks. Then after the end of this period, they received 150 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5 days starting from day 3 of menstruation. Patients continued treatment for three successive cycles using the same protocol. Metformin was stopped only when pregnancy was documented.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Letrozole tablets (Femara; Novartis Pharma, Switzerland), metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)
- Keywords
- Polycystic ovary syndrome, clomiphene resistance, letrozole
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole tablets (Femara; Novartis Pharma, Switzerland)Drug
2.5 mg letrozole daily from day 3 of the menses for 5 days
metformin HCl (Cidophage®; CID,Cairo, Egypt)Drug
metformin HCl 1500 daily for 6-8 weeks
CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)Drug
150 mg CC for 5 days starting from day 3 of menstruation
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Experimental | Not described Receives: Drug: Letrozole tablets (Femara; Novartis Pharma, Switzerland) |
| Metformin-CC | Active comparator | Not described Receives: Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt); Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Principally the ovulation rate as well as the number of growing and mature follicles, serum E2 (pg/ml), serum P (ng/mL), and endometrial thickness (mm).
Secondary outcomes (1)
The occurrence of pregnancy and miscarriage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startJun 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- Hatem Abu Hashim, MD. MRCOG, Principal investigator, Mansoura University HospitalTarek Shokair, MD, Study director, Mansoura University HospitalAhmed Badawy, MD.PhD., Study chair, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911313
- Sponsor's protocol ID
- MU- 059
- Other IDs
- FMH-012-G
- Status last verified
- May 2009
- First submitted
- 28 May 2009
- Last updated
- 1 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. doi: 10.1016/j.fertnstert.2005.05.078.
PubMed 16595197Siebert TI, Kruger TF, Steyn DW, Nosarka S. Is the addition of metformin efficacious in the treatment of clomiphene citrate-resistant patients with polycystic ovary syndrome? A structured literature review. Fertil Steril. 2006 Nov;86(5):1432-7. doi: 10.1016/j.fertnstert.2006.06.014. Epub 2006 Sep 27.
PubMed 17007847
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole Versus Combined Metformin and Clomiphene Citrate for Ovulation Induction in Clomiphene-Resistant Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT00911313
- Acronym / sponsor ID
- MU- 059
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic ovary syndrome, clomiphene resistance, letrozole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 1 Jun 2009 (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.
The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.
Detailed description
Withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation. In the letrozole group, 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days, whereas all patients in the combined metformin-CC group) received metformin HCl [Cidophage®; Chemical Industries Development(CID), Cairo, Egypt], 500 mg three times daily for 6-8 weeks. Then after the end of this period, they received 150 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5 days starting from day 3 of menstruation. Patients continued treatment for three successive cycles using the same protocol. Metformin was stopped only when pregnancy was documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Experimental | Drug: Letrozole tablets (Femara; Novartis Pharma, Switzerland) |
| Metformin-CC | Active comparator | Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt), Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) |
Who may qualify
- Ages
- 20 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- CC resistant PCOS
Key exclusion criteria (3 listed)
- Congenital adrenal hyperplasia
- Cushing syndrome
- Androgen secreting tumors
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 |
|---|---|---|
| Letrozole tablets (Femara; Novartis Pharma, Switzerland)2.5 mg letrozole daily from day 3 of the menses for 5 days | Drug | Letrozole |
| metformin HCl (Cidophage®; CID,Cairo, Egypt)metformin HCl 1500 daily for 6-8 weeks | Drug | Metformin-CC |
| CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)150 mg CC for 5 days starting from day 3 of menstruation | Drug | Metformin-CC |
Primary outcome
Principally the ovulation rate as well as the number of growing and mature follicles, serum E2 (pg/ml), serum P (ng/mL), and endometrial thickness (mm).
1 secondary outcome
The occurrence of pregnancy and miscarriage.
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 1 Jun 2009.
- Background: PubMed 16595197Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. doi: 10.1016/j.fertnstert.2005.05.078.
- Background: PubMed 17007847Siebert TI, Kruger TF, Steyn DW, Nosarka S. Is the addition of metformin efficacious in the treatment of clomiphene citrate-resistant patients with polycystic ovary syndrome? A structured literature review. Fertil Steril. 2006 Nov;86(5):1432-7. doi: 10.1016/j.fertnstert.2006.06.014. Epub 2006 Sep 27.
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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.
Hatem Abu Hashim, MD. MRCOG principal investigator
Mansoura University Hospital
Tarek Shokair, MD study director
Mansoura University Hospital
Ahmed Badawy, MD.PhD. study chair
Mansoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letrozole tablets (Femara; Novartis Pharma, Switzerland), metformin HCl (Cidophage®; CID,Cairo, Egypt) and CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) in people with Polycystic Ovary Syndrome, run by Mansoura 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 1 inclusion and 3 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 1 Jun 2009. 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.
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?
Principally the ovulation rate as well as the number of growing and mature follicles, serum E2 (pg/ml), serum P (ng/mL), and endometrial thickness (mm).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00911313, which also lists 2 linked publications.
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 1 Jun 2009.