Back to resultsLetrozole or Combined Metformin Clomiphene Citrate (CC) for Women With CC Resistant Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Letrozole tablets (Femara; Novartis Pharma, Switzerland)
metformin HCl (Cidophage®; CID,Cairo, Egypt)
CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome, clomiphene resistance, letrozole
Eligibility Criteria
Inclusion Criteria:
- CC resistant PCOS
Exclusion Criteria:
- Congenital adrenal hyperplasia
- Cushing syndrome
- Androgen secreting tumors
Sites / Locations
- Mansoura University Hospitals,OB/GYN department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Letrozole
Metformin-CC
Arm Description
Outcomes
Primary Outcome Measures
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 Outcome Measures
The occurrence of pregnancy and miscarriage.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00911313
Brief Title
Letrozole or Combined Metformin Clomiphene Citrate (CC) for Women With CC Resistant Polycystic Ovary Syndrome
Official Title
Letrozole Versus Combined Metformin and Clomiphene Citrate for Ovulation Induction in Clomiphene-Resistant Women With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic ovary syndrome, clomiphene resistance, letrozole
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Letrozole
Arm Type
Experimental
Arm Title
Metformin-CC
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Letrozole tablets (Femara; Novartis Pharma, Switzerland)
Intervention Description
2.5 mg letrozole daily from day 3 of the menses for 5 days
Intervention Type
Drug
Intervention Name(s)
metformin HCl (Cidophage®; CID,Cairo, Egypt)
Intervention Description
metformin HCl 1500 daily for 6-8 weeks
Intervention Type
Drug
Intervention Name(s)
CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)
Intervention Description
150 mg CC for 5 days starting from day 3 of menstruation
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The occurrence of pregnancy and miscarriage.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CC resistant PCOS
Exclusion Criteria:
Congenital adrenal hyperplasia
Cushing syndrome
Androgen secreting tumors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem Abu Hashim, MD. MRCOG
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tarek Shokair, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed Badawy, MD.PhD.
Organizational Affiliation
Mansoura University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University Hospitals,OB/GYN department
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
16595197
Citation
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.
Results Reference
background
PubMed Identifier
17007847
Citation
Siebert 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.
Results Reference
background
Learn more about this trial
Letrozole or Combined Metformin Clomiphene Citrate (CC) for Women With CC Resistant Polycystic Ovary Syndrome
We'll reach out to this number within 24 hrs