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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00478504
Other study ID # RD-5103-015-06
Secondary ID EudraCT No: 2006
Status Completed
Phase Phase 4
First received May 23, 2007
Last updated October 26, 2016
Start date May 2007
Est. completion date September 2014

Study information

Verified date October 2016
Source University of Nottingham
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
Study type Interventional

Clinical Trial Summary

The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than the current standard agent, clomifene citrate in anovular infertile women with polycystic ovarian syndrome.


Recruitment information / eligibility

Status Completed
Enrollment 159
Est. completion date September 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria:

1. Age: 18 - 39

2. BMI < 36

3. Infertility due to anovulation

4. PCOS: At least two of the following diagnostic criteria of:

1. Oligo/amenorrhoea

2. Hyperandrogenaemia: biochemical (testosterone =2.5 nmol/l or free androgen index (FAI) = 5) or clinical (acne/hirsutism) evidence

3. USS evidence of PCO (either =12 follicles measuring 2-9 mm in diameter, or an ovarian volume of > 10 ml)

5. No recent (within 6 months) treatment for induction of ovulation

6. Normal semen analysis (WHO 1999)

7. Proven patency of at least one Fallopian tube

Exclusion Criteria:

1. Inability to give informed consent

2. Contraindication to letrozole or clomifene citrate

3. Absence of any inclusion criteria

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Letrozole
Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg
Clomifene citrate
Starting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg

Locations

Country Name City State
United Kingdom Royal Derby Hospital Derby Derbyshire

Sponsors (2)

Lead Sponsor Collaborator
University of Nottingham Derby Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pregnancy rate 14 moths No
Secondary 1. Ovulation rate 2. Number of growing and mature follicles during treatment 3. Miscarriage rate 4. Live-birth rate 5. Multiple pregnancy rate 6. Endometrial thickness 14 months No
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