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Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

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ClinicalTrials.gov Identifier: NCT00317928
Recruitment Status : Unknown
Verified August 2001 by Aarhus University Hospital Skejby.
Recruitment status was:  Active, not recruiting
First Posted : April 25, 2006
Last Update Posted : October 11, 2006
Sponsor:
Collaborators:
Regional Hospital Holstebro
Aarhus University Hospital
Information provided by:
Aarhus University Hospital Skejby

Brief Summary:

Hypothesis: Metformin treatment normalises hormone values and metabolic parameters in women with PCOS. Ovulation is restored and bleeding periods become regular.

Fifty women with PCOS (Rotterdam criteria) are randomised to either placebo or metformin for 6 months. After a wash-out period of 3 months, the opposite treatment is given for another 6 months. Measurements are performed before ech treatment period, every second month during treatment and after completing treatment.


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 2001
Study Completion Date : September 2004

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of PCOS
  • Age 20 - 45

Exclusion Criteria:Diabetes

  • Diabetes
  • Hormonal treatment
  • Pregnancy, lactation
  • Periclimacteric

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317928


Sponsors and Collaborators
Aarhus University Hospital Skejby
Regional Hospital Holstebro
Aarhus University Hospital
Investigators
Principal Investigator: Ditte Trolle, MD Skejby University Hospital, Aarhus, Denmark

ClinicalTrials.gov Identifier: NCT00317928     History of Changes
Other Study ID Numbers: 160350-1
First Posted: April 25, 2006    Key Record Dates
Last Update Posted: October 11, 2006
Last Verified: August 2001

Keywords provided by Aarhus University Hospital Skejby:
Polycystic Ovary Syndrome
Metformin
Metabolic Syndrome
Hyperandrogenism
Ovulation

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs