Trial With Metformin in Women With Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

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

Study Description

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 Design


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

Genetics Home Reference related topics: Polycystic ovary syndrome

MedlinePlus related topics: Polycystic Ovary Syndrome

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Other Outcome Measures:

Body weight change [ Time Frame: Six months ]
Body weight changes

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

Contacts and Locations

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

More Information

Publications of Results:

Trolle B, Flyvbjerg A, Kesmodel U, Lauszus FF. Efficacy of metformin in obese and non-obese women with polycystic ovary syndrome: a randomized, double-blinded, placebo-controlled cross-over trial. Hum Reprod. 2007 Nov;22(11):2967-73. Epub 2007 Aug 31.

Trolle B, Lauszus FF, Frystyk J, Flyvbjerg A. Adiponectin levels in women with polycystic ovary syndrome: impact of metformin treatment in a randomized controlled study. Fertil Steril. 2010 Nov;94(6):2234-8. doi: 10.1016/j.fertnstert.2010.01.057. Epub 2010 Mar 2.

Greibe E, Trolle B, Bor MV, Lauszus FF, Nexo E. Metformin lowers serum cobalamin without changing other markers of cobalamin status: a study on women with polycystic ovary syndrome. Nutrients. 2013 Jul 5;5(7):2475-82. doi: 10.3390/nu5072475.

Madsen HN, Lauszus FF, Trolle B, Ingerslev HJ, Tørring N. Impact of metformin on anti-Müllerian hormone in women with polycystic ovary syndrome: a secondary analysis of a randomized controlled trial. Acta Obstet Gynecol Scand. 2015 May;94(5):547-51. doi: 10.1111/aogs.12605. Epub 2015 Mar 4.


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

To Top