Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

February 6, 2008 updated by: Sun Pharmaceutical Industries Limited

An Open, Randomized, Parallel-Group, Multicentric, Comparative Study of Letrozole With Clomiphene Citrate for Induction of Ovulation in Anovulatory Infertility.

OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in patients with anovulatory infertility. DESIGN: Open, prospective, randomized, parallel group, multicentric, comparative trial. SETTING: Out patient clinics of infertility centers in India. PATIENT(S): Fifty-five patients with anovulatory infertility were recruited. Twenty-seven patients (59 cycles) were given letrozole and twenty-eight patients (68 cycles) were given CC. Both drugs were given orally on days 3-7 of menstrual cycle. INTERVENTION(S): Letrozole, CC, ovulation induction, vaginal micronized progesterone, IUI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

MAIN OUTCOME MEASURE(S): Occurrence of ovulation, endometrial thickness and pregnancy rates.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai-, Maharashtra, India, 400071
        • IVF Centre, Chembur,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females with anovulatory infertility 20-38 years of age.
  • Diagnosis of anovulatory infertility as established by standard criteria.
  • Normal Pelvic USG and bilateral tubal patency
  • Willingness and giving written Informed Consent.

Exclusion Criteria:

  • Uterine and adnexal pathology e.g. leiomyomata
  • Ovarian cyst
  • Hyperprolactinaemia
  • Hyperthyroidism or Hypothyroidism*
  • FSH >9mIU/ml (during early follicular phase).* (As per Chemoluminescence method)
  • Previous surgery related to genital tract as per history
  • Appendicitis, peritonitis, genital tuberculosis as per history and/or having an abnormal pelvic anatomy
  • Impaired hepatic /renal function
  • Diabetes mellitus/Random blood sugar- > 140mg/dl
  • Drugs likely to interfere with ovulation
  • Alcohol intake as per history
  • History of hypersensitivity to the study drug or to its excipients
  • Planned travel outside the study area for a substantial portion (>5 days) of the study period by potential participants
  • Lack of willingness to give informed written consent
  • Participation in any clinical study within the preceding 1 month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Letrozole
Drug: Letrozole
Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles
Other Names:
  • Letroz
Active Comparator: 2
Clomiphene citrate
Drug: Clomiphene citrate
Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles
Other Names:
  • Ferotab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG).
Time Frame: 3 cycles
3 cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography.
Time Frame: 3 cycles
3 cycles
Safety
Time Frame: 3 cycles
3 cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharmaceutical Industries Limited

Investigators

  • Principal Investigator: Mandakini Parihar, M.D., D.G.O., Director, IVF Centre, Chembur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

February 6, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Estimate)

February 7, 2008

Last Update Submitted That Met QC Criteria

February 6, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LET/SPIL/03/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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