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Trial With Metformin in Women With Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT02280057
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
GEA A/S Denmark
Information provided by (Responsible Party):
Finn Friis Lauszus, Herning Hospital

Brief Summary:
The investigators wanted to elucidate the effects of metformin in Polycystic Ovary Syndrome (PCOS) by performing a randomized, double-blinded, placebo-controlled cross-over study.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Drug: Placebo Phase 4

Detailed Description:

Eligible women who gave written informed consent were assigned to 6 months of treatment with either 850 mg of metformin or placebo twice daily, followed by a wash-out period of 3 months before cross-over to the alternate treatment for another 6 months. Randomization defining treatment sequence was done at inclusion by random number tables. The appearance of the tablets was identical, and patients and investigators were blinded to treatment allocation. The randomization code was stored in a closed envelope until all participants had finished the treatment. Participants were seen by one of the investigators before inclusion and every second month during treatment periods, always in the morning after an overnight fast of at least 8 h. They were weighed wearing light clothing. Waist circumference was measured at the umbilical level and hip circumference at the trochanter region. Systolic and diastolic blood pressure was measured with a semiautomatic blood pressure monitor and a blood sample was drawn for immediate analysis without respect to bleeding periods. All participants registered their bleeding periods in a calendar during both study periods and the 3 months wash-out period. Calculation of sample size was based on the assumption that at least 50% of the women would experience at least 30% more menstrual periods on metformin than on placebo. Based on a power of 90 (b = 0.10) to detect a significant difference [two-sided P-value of 0.05], the minimum sampling size was calculated to 44 subjects.

We also assumed a 10% drop-out rate, and thus aimed at including 50 women. As drop-out rate quickly rose higher than expected, we decided to include 60 women. In the intention-to-treat analysis, the values of each participant after 6 months of metformin or placebo were compared with the baseline values. Linear regression analysis with the changes in testosterone and homeostasis model assessment (HOMA) index as dependent variables was performed to examine potential relations between the changes. The per protocol analysis included data from participants completing both study periods, i.e. the difference between the values of each participant after placebo and metformin, respectively, was calculated, and a significance test performed on the differences.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomized, Cross-over Trial With Metformin in Women With Polycystic Ovary Syndrome
Study Start Date : September 2001
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Metformin
Metformin 850 mg x 2 in six months
Drug: Metformin
Metformin 1500 mg (=2 pills) per day in six months
Placebo Comparator: Placebo
Placebo 2 tablets daily for six months
Drug: Placebo
2 pills per day in six months; pills look like metformin pills



Primary Outcome Measures :
  1. Testosterone (Levels of free testosterone) [ Time Frame: six months ]
    Levels of free testosterone


Secondary Outcome Measures :
  1. Insulin sensitivity (measured homeostasis model assessment (HOMA) index) [ Time Frame: Six months ]
    Insulin sensitivity measured homeostasis model assessment (HOMA) index


Other Outcome Measures:
  1. Body weight change [ Time Frame: Six months ]
    Body weight changes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT02280057


Locations
Denmark
Gynecology Dept. Herning Hospital
Herning, Denmark, 7400
Sponsors and Collaborators
Herning Hospital
GEA A/S Denmark
Investigators
Principal Investigator: Finn F Lauszus, MD, PhD Gyn Dept. Herning Hospital, Herning, Denmark

Publications of Results:
Responsible Party: Finn Friis Lauszus, Senior Consultant, Herning Hospital
ClinicalTrials.gov Identifier: NCT02280057     History of Changes
Other Study ID Numbers: 2166-00
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Finn Friis Lauszus, Herning Hospital:
PCOS
metformin
obesity
randomized controlled trial

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