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Letrozole or Combined Clomiphene Citrate Metformin as a First Line Treatment in Women With Polycystic Ovarian Syndrome (PCO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ahmed ali, Assiut University
ClinicalTrials.gov Identifier:
NCT01679574
First received: August 31, 2012
Last updated: September 6, 2012
Last verified: September 2012
History of Changes
  Purpose

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 treated before with any ovulation induction agent


Condition Intervention
Polycystic Ovary Syndrome
 Drug: Letrozole
Drug: Clomiphene
Drug: Metformin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Letrozole Versus Clomiphene Citrate Plus Metformin in the First Treatment of Infertility in Patients With Polycystic Ovarian Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assiut University:

Primary Outcome Measures:
  • ovulation rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Principally the ovulation rate as well as the number of growing and mature follicles and endometrial thickness (mm).


Secondary Outcome Measures:
  • The occurrence of pregnancy and miscarriage [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The occurrence of pregnancy and miscarriage


Enrollment: 200
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: letrozole
Letrozole tablets (Femara; Novartis Pharma, Switzerland) 2.5 mg letrozole daily from day 3 of the menses for 5 days
 Drug: Letrozole
•Drug: Letrozole tablets (Femara; Novartis Pharma, Switzerland) 2.5 mg letrozole daily from day 3 of the menses for 5 days
Other Name: Femara; Novartis Pharma, Switzerland
Active Comparator: Metformin and clomiphene

.Drug: metformin (Cidophage®; CID,Cairo, Egypt) metformin 1500 daily for 3 months

  • Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) 100 mg CC for 5 days starting from day 3 of menstruation
 Drug: Clomiphene
•Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) 100 mg CC for 5 days starting from day 3 of menstruation
Other Name: clomid
Drug: Metformin
•Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt) metformin HCl 1500 daily for 3 months
Other Name: Cidophage

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All participants met the Rotterdam consensus criteria for the diagnosis of PCOS . .Primary infertility because of anovulation for at least 1 year.
  • Only fresh (not treated previously) cases were recruited. .The male partner of each participant was required to have a normal result on semen analysis (count>20million/ml,motility>40%and normal morphology >30%).
  • Each woman was required to have patent tubes on hysterosalpingography or on a diagnostic laparoscopy.

Exclusion Criteria:

  • Age below 18 years or above 35 years , trial of ovulation induction prior to the stud ,BMI >35 .
  • Presence of other causes of infertility; hyperprolactinemia (morning plasma prolactin concentration 30 ng/mL or more); any other endocrine, hepatic, or renal disorder; presence of an organic pelvic mass;
  • History of abdominal surgery that might have caused pelvic factor infertility.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679574

Locations
Egypt
Assiut University
Assiut, Egypt, 11111
Sponsors and Collaborators
Assiut University
Investigators
Study Chair: Tarek al Hussaini, prof assiut university hospital
Study Director: Safowt Abd El Rady, Prof Assiut university hosiptal
Study Director: Mohamad S Abd Allah, Ass prof assiut university hosital
  More Information

No publications provided

Responsible Party: ahmed ali, Prinicple investigator, Assiut University
ClinicalTrials.gov Identifier: NCT01679574     History of Changes
Other Study ID Numbers: pcolcm
Study First Received: August 31, 2012
Last Updated: September 6, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by Assiut University:
PCO

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Clomiphene
Metformin
Letrozole
Estrogen Antagonists
Estrogen Receptor Modulators
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Hypoglycemic Agents
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013