Trial With Metformin in Women With Polycystic Ovary Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02280057
• Date of registration: 28/10/2014
• Prospective Registration: No
• Primary sponsor: Herning Hospital
• Public title: Trial With Metformin in Women With Polycystic Ovary Syndrome
• Scientific title: Randomized, Cross-over Trial With Metformin in Women With Polycystic Ovary Syndrome
• Date of first enrolment: September 2001
• Target sample size: 56
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02280057
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 4

Countries of recruitment

Denmark

Contacts

• Name: Finn F Lauszus, MD, PhD
• Affiliation: Gyn Dept. Herning Hospital, Herning, Denmark

Key inclusion & exclusion criteria

Inclusion Criteria:

- testosterone value above the upper normal limit and

- oligo- or amenorrhea,

Exclusion Criteria:

- periclimacteric gonadotrophin values,

- hyperprolactinaemia,

- diabetes mellitus,

- impaired thyroid,

- renal or hepatic function,

- hormonal treatment,

- pregnancy,

- lactation or a wish for fertility treatment.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Polycystic Ovary Syndrome

Intervention(s)

Drug: Metformin

Drug: Placebo

Primary Outcome(s)

Testosterone (Levels of free testosterone) [Time Frame: six months]

Secondary Outcome(s)

Insulin sensitivity (measured homeostasis model assessment (HOMA) index) [Time Frame: Six months]

Secondary ID(s)

2166-00

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GEA A/S Denmark