Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

NCT ID: NCT05965908

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-30

Study Completion Date

2023-10-30

Brief Summary

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

Detailed Description

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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

Conditions

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Polycystic Ovary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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liraglutide

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

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

glucagon-like peptide 1 receptor agonist

metformin

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

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

biguanide antihyperglycemic

control

not given any drug

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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liraglutide

glucagon-like peptide 1 receptor agonist

Intervention Type DRUG

Metformin

biguanide antihyperglycemic

Intervention Type DRUG

Other Intervention Names

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saxenda ampoules Glucophage 1000mg

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Sara Abdallah Mohamed Salem

Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beni-Suef University

Role: STUDY_DIRECTOR

Clinical Pharmacy Faculty of Pharmacy Beni-Suef University

Locations

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Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Sara A Salem, MD

Role: CONTACT

01272842226 ext. 02

Other Identifiers

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Liraglutide Polycystic Ovary

Identifier Type: -

Identifier Source: org_study_id

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