NCT00610077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
Last Updated

February 7, 2008

Status Verified

January 1, 2008

Enrollment Period

1.6 years

First QC Date

January 24, 2008

Last Update Submit

February 6, 2008

Conditions

Infertility

Keywords

LetrozoleClomiphene citrateAnovulatory infertilityOvulation induction

Outcome Measures

Primary Outcomes (1)

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

    3 cycles

Secondary Outcomes (2)

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

    3 cycles

  • Safety

    3 cycles

Study Arms (2)

1

EXPERIMENTAL

Letrozole

Drug: Letrozole

2

ACTIVE COMPARATOR

Clomiphene citrate

Drug: Clomiphene citrate

Interventions

LetrozoleDRUG

Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles

Also known as: Letroz
1
Clomiphene citrateDRUG

Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles

Also known as: Ferotab
2

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVF Centre, Chembur,

Mumbai, Maharashtra, 400071, India

Location

MeSH Terms

Conditions

Infertility

Interventions

LetrozoleClomiphene

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Mandakini Parihar, M.D., D.G.O.

    Director, IVF Centre, Chembur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 24, 2008

First Posted

February 7, 2008

Study Start

December 1, 2004

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

February 7, 2008

Record last verified: 2008-01

Locations

IN(1)