A randomised controlled clinical trial of metformin versus orlistat for the management of obses anovulatory women - n/a

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002096-32-GB

Enrollment

Registered

2005-11-03

Start date

2005-12-02

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anovulatory Obese Women

Interventions

Trade Name: Metformin Product Name: Metformin Product Code: n/a Pharmaceutical Form: Tablet Trade Name: Xenecal Product Name: Orlistat Pharmaceutical Form: Capsule*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Obese women with abody mas index of 30 or more 2. Anovulatory as shown by a day 21-serum progesterone Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. DIABETES 2.PATIENTS WITH ANY CONTRAINDICATIONS TOE THE USE OF METFROMIN OR ORLISTAT AS STATED IN THE NF

Design outcomes

Primary

Measure	Time frame
Main Objective: In obese anovulatory patients would the use of metformin or orlisata lead to the achievement of ovulation;Secondary Objective: 1. Is there a difference in reponse to metformin and/or orlistat in obese anovulatory patients with or wiyhout polycystic ovarian syndrome 2. If metformin proves ot have beneficial effect, then what is the optimal dose 3. What is the effect of metformin and orlistat on the ovarian vasculature;Primary end point(s): Ovulation Improvement/deterioration in clinical symptoms: hyper androgenic features, obesity and menstrual disturbances Change in ovarian doppler indicies Preganancy BMI<30	—

Measure

Time frame

Main Objective: In obese anovulatory patients would the use of metformin or orlisata lead to the achievement of ovulation;Secondary Objective: 1. Is there a difference in reponse to metformin and/or orlistat in obese anovulatory patients with or wiyhout polycystic ovarian syndrome 2. If metformin proves ot have beneficial effect, then what is the optimal dose 3. What is the effect of metformin and orlistat on the ovarian vasculature;Primary end point(s): Ovulation Improvement/deterioration in clinical symptoms: hyper androgenic features, obesity and menstrual disturbances Change in ovarian doppler indicies Preganancy BMI<30

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026