Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility - Tabular View

Tracking Information

First Received Date ^ICMJE

January 24, 2008

Last Updated Date

February 6, 2008

Start Date ^ICMJE

December 2004

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG). [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00610077 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography. [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]
Safety [ Time Frame: 3 cycles ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

Official Title ^ICMJE

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Infertility

Intervention ^ICMJE

Drug: Letrozole
Drug: Clomiphene citrate

Study Arms / Comparison Groups

Experimental: Letrozole
Active Comparator: Clomiphene citrate

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2006

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

20 Years to 38 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

India

Administrative Information

NCT ID ^ICMJE

NCT00610077

Responsible Party

Medical Advisor, Sun Pharmaceutical Industries Limited

Study ID Numbers ^ICMJE

LET/SPIL/03/06

Study Sponsor ^ICMJE

Sun Pharmaceutical Industries Limited

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Mandakini Parihar, M.D., D.G.O.

Director, IVF Centre, Chembur

Information Provided By

Sun Pharmaceutical Industries Limited

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP