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Letrozole Versus Clomifene Citrate for Ovulation Induction

This study has been completed.
Sponsor:
Collaborator:
Derby Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Saad Amer, University of Nottingham
ClinicalTrials.gov Identifier:
NCT00478504
First received: May 23, 2007
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than the current standard agent, clomifene citrate in anovular infertile women with polycystic ovarian syndrome.

Condition Intervention Phase
Infertility
Polycystic Ovarian Syndrome
Drug: Letrozole
Drug: Clomifene citrate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Cross-over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: 14 moths ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. Ovulation rate 2. Number of growing and mature follicles during treatment 3. Miscarriage rate 4. Live-birth rate 5. Multiple pregnancy rate 6. Endometrial thickness [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Enrollment: 159
Study Start Date: May 2007
Study Completion Date: September 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clomiphene citrate
Starting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg
Drug: Clomifene citrate
Starting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg
Active Comparator: Letrozole
Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg
Drug: Letrozole
Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: 18 - 39
  2. BMI < 36
  3. Infertility due to anovulation
  4. PCOS: At least two of the following diagnostic criteria of:

    1. Oligo/amenorrhoea
    2. Hyperandrogenaemia: biochemical (testosterone ≥2.5 nmol/l or free androgen index (FAI) ≥ 5) or clinical (acne/hirsutism) evidence
    3. USS evidence of PCO (either ≥12 follicles measuring 2-9 mm in diameter, or an ovarian volume of > 10 ml)
  5. No recent (within 6 months) treatment for induction of ovulation
  6. Normal semen analysis (WHO 1999)
  7. Proven patency of at least one Fallopian tube

Exclusion Criteria:

  1. Inability to give informed consent
  2. Contraindication to letrozole or clomifene citrate
  3. Absence of any inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478504

Locations
United Kingdom
Royal Derby Hospital
Derby, Derbyshire, United Kingdom, DE22 3NE
Sponsors and Collaborators
University of Nottingham
Derby Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Saad Amer, MD, MRCOG University of Nottingham and Derby Hospitals NHS foundation Trust
  More Information

Additional Information:
Responsible Party: Saad Amer, Associate Professor, University of Nottingham
ClinicalTrials.gov Identifier: NCT00478504     History of Changes
Other Study ID Numbers: RD-5103-015-06  EudraCT No: 2006-006514-15 
Study First Received: May 23, 2007
Last Updated: October 26, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by University of Nottingham:
anovulation
ovulation induction,
polycystic ovarian syndrome
clomifene citrate
letrozole

Additional relevant MeSH terms:
Syndrome
Infertility
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Clomiphene
Enclomiphene
Zuclomiphene
Letrozole
Citric Acid
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Anticoagulants
Calcium Chelating Agents

ClinicalTrials.gov processed this record on December 07, 2016