PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study was to determine whether monotherapy treatment with phosphodiesterase-4 (PDE-4) inhibitor roflumilast is more effective than treatment with glucagon-like protein 1 (GLP-1) liraglutide or treatment with metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) regarding weight reduction who have not been treated before. The investigators anticipated greater changes in body weight in patients on roflumilast treatment than in liraglutide or metformin.

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Detailed Description

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Conditions

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PCOS Obesity

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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metformin

In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 2x1000 mg BID per os.

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

liraglutide

In the liraglutide group liraglutide was initiated at a dose of 0,6mg sc once per day for one week and increased to 1,2mg sc one per day.

Group Type ACTIVE_COMPARATOR

liraglutide

Intervention Type DRUG

roflumilast

In the roflumilast group roflumilast was initiated at a dose of 500 mg BID per os.

Group Type ACTIVE_COMPARATOR

roflumilast

Intervention Type DRUG

Interventions

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metformin

Intervention Type DRUG

liraglutide

Intervention Type DRUG

roflumilast

Intervention Type DRUG

Other Intervention Names

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Eligibility Criteria

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Inclusion Criteria

* 18 years old to menopause
* polycystic ovary syndrome (NICHD criteria)
* BMI of 30 kg/m² or higher

Exclusion Criteria

* depression
* type 1 or type 2 diabetes mellitus
* history of carcinoma
* history of pancreatitis
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* significant cardiovascular, kidney or hepatic disease
* the use of medications other than metformin known or suspected to affect reproductive or metabolic functions
* the use of statins, within 90 days prior to study entry

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No