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

Purpose

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.

Condition	Intervention	Phase
Infertility	Drug: Letrozole Drug: Clomiphene citrate	Phase III

MedlinePlus related topics:

Infertility Ultrasound

ChemIDplus related topics:

Citric acid Sodium Citrate Clomiphene citrate Clomiphene Enclomiphene Zuclomiphene Letrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Sun Pharmaceutical Industries Limited:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	55
Study Start Date:	December 2004
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Letrozole	Drug: Letrozole Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles
2: Active Comparator Clomiphene citrate	Drug: Clomiphene citrate Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles

Detailed Description:

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

Eligibility

Ages Eligible for Study:	20 Years to 38 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610077

Locations


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

Sponsors and Collaborators

Sun Pharmaceutical Industries Limited

Investigators


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

More Information

Responsible Party:	Sun Pharmaceutical Industries Limited ( Medical Advisor )
Study ID Numbers:	LET/SPIL/03/06
First Received:	January 24, 2008
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00610077
Health Authority:	India: Drugs Controller General of India

Keywords provided by Sun Pharmaceutical Industries Limited:

Letrozole

Clomiphene citrate

Anovulatory infertility

Ovulation induction

Study placed in the following topic categories:

Genital Diseases, Female

Infertility

Citric Acid

Clomiphene

Letrozole

Genital Diseases, Male

Additional relevant MeSH terms:

Estrogen Antagonists

Anticoagulants

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Hormone Antagonists

Hematologic Agents

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Enzyme Inhibitors

Reproductive Control Agents

Selective Estrogen Receptor Modulators

Pharmacologic Actions

Estrogen Receptor Modulators

Therapeutic Uses

Fertility Agents, Female

Fertility Agents

Chelating Agents

Aromatase Inhibitors

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Sun Pharmaceutical Industries Limited
Information provided by:	Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier:	NCT00610077