Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy

NCT00283816 | Completed Phase 3 Results DMC

• 2 other identifiers: RSRB-00012501GCRC#1083
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic state. This study is to determine whether metformin added to oral contraceptive therapy in adolescent women with PCOS improves metabolic state.The study will also test a lifestyle improvement program to reduce weight.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; Overweight Adolescent Girls; Irregular Menstrual Cycles

Outcome Measures

Primary Outcomes (1)

• Reduction in Abdominal Fat as Measured by Waist Circumference.

  Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention

  baseline and 24 weeks

Secondary Outcomes (3)

• Change in Weight Post Minus Pre Intervention.

  baseline and 24 weeks

• Total Testosterone Change

  baseline and 24 weeks

• Change in Sex Hormone Binding Globulin (SHBG)

  baseline and 24 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

metformin

Drug: Metformin; Drug: Oral Contraceptive Pill; Behavioral: Lifestyle Management Program; Behavioral: Quality of Life Questionnaire; Procedure: Oral Glucose Tolerance Test; Procedure: Blood work; Procedure: Abdominal Ultra Sound; Procedure: Dual-energy x-ray absorptiometry (DEXA scan)

0

PLACEBO COMPARATOR

placebo

Drug: Oral Contraceptive Pill; Behavioral: Lifestyle Management Program; Behavioral: Quality of Life Questionnaire; Procedure: Oral Glucose Tolerance Test; Procedure: Blood work; Procedure: Abdominal Ultra Sound; Procedure: Dual-energy x-ray absorptiometry (DEXA scan); Drug: placebo

Interventions

Metformin DRUG

Metformin 500 mg. tabs 2 tabs BID for duration of study

Also known as: Metformin Hydrochloride Tablets, 500 mg., manufacturer: Mylan Pharmaceuticals, Morgantown, WV

1

Oral Contraceptive Pill DRUG

Yasmin, drospirenone and ethinyl estradiol 28 tablets 1 tab daily for duration of study

Also known as: Yasmin 28 tablets, Manufacturer: Berlex, Montville, NJ 07045

0; 1

Lifestyle Management Program BEHAVIORAL

Subjects and a parent/guardian will participate in a series of classes for training in diet, exercise \& behavior modification skills on a regular weekly basis over the 24 week study

0; 1

Quality of Life Questionnaire BEHAVIORAL

Quality of Life questionnaire designed for women with Polycystic Ovary Syndrome. Questions concern health and health related issues Performed twice during study, at baseline and conclusion

0; 1

Oral Glucose Tolerance Test PROCEDURE

Insulin response to a glucose challenge in an oral glucose tolerance test (OGTT), as measured by area under the curve (AUC). In this study we will administer an OGTT and calculate the AUC as a measure of insulin resistance. Performed twice during study, at baseline and conclusion

0; 1

Blood work PROCEDURE

Initial and conclusion blood draws include; comprehensive metabolic profile, CBC and platelet,hormonal assessment and lipids.

0; 1

Abdominal Ultra Sound PROCEDURE

transabdominal transducer, which contains integrated software for volume calculation will be used to assess ovarian volume. Performed twice during study, at baseline and conclusion

0; 1

Dual-energy x-ray absorptiometry (DEXA scan) PROCEDURE

Dual-energy x-ray absorptiometry (DEXA) will be used to assess percent body fat Performed twice during study, at baseline and conclusion

0; 1

placebo DRUG

placebo capsules, two capsules BID

Also known as: placebo formulation: 240 mg. lactose powder USP, in size 3 capsules from Capsugel

0

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Menstruation Disturbances

Interventions

Metformin; Contraceptives, Oral; Glucose Tolerance Test; Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical

Results Point of Contact

• Title: Kathleen M. Hoeger, MD, MPH
• Organization: University of Rochester Medical Center

Kathy_Hoeger@urmc.rochester.edu

585-275-7891

Study Officials

• Kathleen Hoeger, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2006
• First Posted: January 30, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 15, 2015
• Results First Posted: July 13, 2011

Record last verified: 2011-04

Locations

US (1)