PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome

University Medical Centre Ljubljana

Status and phase: Completed; Phase 4

Conditions: PCOS; Obesity

Treatments: Drug: metformin and roflumilast; Drug: metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02037672

DAXAS

Details and patient eligibility

About

The purpose of this study was to determine whether combined treatment with phosphodiesterase-4 (PDE-4) inhibitor roflumilast and metformin is more effective than metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders regarding weight reduction on metformin monotherapy. The investigators anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy with metformin.

Enrollment: 36 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
• 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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36 participants in 2 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 1000 mg BID per os.

Treatment:

Drug: metformin

metformin and roflumilast

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 1000 mg BID per os. At the same time roflumilast was initiated at a dose of 500 mg BID per os.

Treatment:

Drug: metformin and roflumilast