Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

Beni-Suef University

Status and phase: Not yet enrolling; Phase 3

Conditions: Polycystic Ovary

Treatments: Drug: Metformin; Drug: liraglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT05965908

Liraglutide Polycystic Ovary

Details and patient eligibility

About

The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and liraglutide in infertile women with PCOs.

Full description

It is a Prospective randomized controlled trial .The study will include 80 randomly selected infertile women aged between 18 and 45 years, from Gynecology and obstetrics department Beni-Suef University Hospital whom diagnosed with polycystic ovarian syndrome (PCOS), The study will include two groups; each group consists of 40 patients:-

• Group1 (n=40) will be treated by liraglutide monotherapy.
• Group 2 (n=40) will be treated by metformin monotherapy.
• Group 3 (n=40) will be a control group.

To assess the metabolic effect of each treatment, the following parameters will be assessed before and after the treatment

• To assess the hormonal effect of each treatment, the following tests will be assessed before and after treatment
• Total Testosterone (TT)
• Dehydroepiandrosterone (DHEA)

To assess the clinical effect of the drugs, the following will be assessed before and after treatment:

The number of medium size follicles and large size follicles and the endometrium thickness were assessed on the tenth or eleventh day of menstruation. The chemical and clinical pregnancy rates were evaluated

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged between 20 and 45 years
• PCO

Exclusion criteria

1. congenital adrenal hyperplasia
2. poorly controlled thyroid disease
3. Taking antidiabetic drugs which can affect insulin resistance
4. chronic kidney disease and history of recurrent urinary tract infections
5. liver dysfunction
6. documented use of oral hormonal contraceptives and hormone-releasing implants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

liraglutide

Experimental group

Description:

Saxenda® starting dose is 0.6 mg per day for 1 week.1. Patients increase the dose by 0.6 mg each week until the full maintenance dose of 3 mg is reached

Treatment:

Drug: liraglutide

metformin

Active Comparator group

Description:

the patient is given Glucophage 1000 mg tab once daily after lunch for 1month

Treatment:

Drug: Metformin

control

No Intervention group

Description:

not given any drug