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

University Medical Centre Ljubljana

Status and phase: Completed; Phase 4

Conditions: PCOS; Obesity

Treatments: Drug: roflumilast; Drug: metformin; Drug: liraglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT02187250

DAXAS 2

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

metformin

Active Comparator group

Description:

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.

Treatment:

Drug: metformin

liraglutide

Active Comparator group

Description:

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.

Treatment:

Drug: liraglutide

roflumilast

Active Comparator group

Description:

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

Treatment:

Drug: roflumilast