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

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

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

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.

Resource links provided by NLM:

MedlinePlus related topics: Infertility Ultrasound

Drug Information available for: Clomiphene citrate Zuclomiphene Enclomiphene Citric acid Letrozole Clomiphene Sodium Citrate trans-Clomifene citrate

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Sun Pharmaceutical Industries Limited:

Letrozole
Clomiphene citrate
Anovulatory infertility
Ovulation induction

Additional relevant MeSH terms:

Infertility
Estrogen Antagonists
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Citric Acid
Hematologic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Clomiphene
Enzyme Inhibitors

Letrozole
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Genital Diseases, Male
Pharmacologic Actions
Genital Diseases, Female
Estrogen Receptor Modulators
Fertility Agents, Female
Therapeutic Uses
Fertility Agents
Chelating Agents
Aromatase Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010