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Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Letrozole
Clomiphene citrate
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Letrozole, Clomiphene citrate, Anovulatory infertility, Ovulation induction

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • IVF Centre, Chembur,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Letrozole

Clomiphene citrate

Outcomes

Primary Outcome Measures

Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG).

Secondary Outcome Measures

Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography.
Safety

Full Information

First Posted
January 24, 2008
Last Updated
February 6, 2008
Sponsor
Sun Pharmaceutical Industries Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00610077
Brief Title
Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility
Official Title
An Open, Randomized, Parallel-Group, Multicentric, Comparative Study of Letrozole With Clomiphene Citrate for Induction of Ovulation in Anovulatory Infertility.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Pharmaceutical Industries Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Letrozole, Clomiphene citrate, Anovulatory infertility, Ovulation induction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Letrozole
Arm Title
2
Arm Type
Active Comparator
Arm Description
Clomiphene citrate
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Letroz
Intervention Description
Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles
Intervention Type
Drug
Intervention Name(s)
Clomiphene citrate
Other Intervention Name(s)
Ferotab
Intervention Description
Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles
Primary Outcome Measure Information:
Title
Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG).
Time Frame
3 cycles
Secondary Outcome Measure Information:
Title
Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography.
Time Frame
3 cycles
Title
Safety
Time Frame
3 cycles

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandakini Parihar, M.D., D.G.O.
Organizational Affiliation
Director, IVF Centre, Chembur
Official's Role
Principal Investigator
Facility Information:
Facility Name
IVF Centre, Chembur,
City
Mumbai-
State/Province
Maharashtra
ZIP/Postal Code
400071
Country
India

12. IPD Sharing Statement

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Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

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