Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

NCT00640224 | Completed Phase 4 Results

• 2 other identifiers: 05030132K24HD001357
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory markers, vascular markers and bone development in overweight adolescent females with polycystic ovary syndrome (PCOS).

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (3)

• Peripheral Insulin Sensitivity at Baseline and 6 Months.

  Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.

  Baseline and 6 months

• Hepatic Insulin Sensitivity at Baseline and 6 Months.

  Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp.

  Baseline and 6 months

• Glucose Tolerance Status at Baseline and 6 Months.

  Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria.

  Baseline and 6 months

Secondary Outcomes (20)

• Total Fat Mass at Baseline and 6 Months

  Baseline and 6 months

• Total Testosterone at Baseline and 6 Months

  Baseline and 6 months

• Percent Body Fat at Baseline and 6 Months

  Baseline and 6 months

• Free Testosterone at Baseline and 6 Months

  Baseline and 6 months

• SHBG at Baseline and 6 Months

  Baseline and 6 months

Study Arms (4)

Rosiglitazone

ACTIVE COMPARATOR

Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone

Drug: rosiglitazone

Drospirenone/ethinyl estradiol

ACTIVE COMPARATOR

Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol

Drug: drospirenone/ethinyl estradiol

Overweight/Obese without PCOS

NO INTERVENTION

Overweight adolescent females without PCOS to use as comparison of normal developmental changes. \*No participants were enrolled in this Arm.

Lean without PCOS

NO INTERVENTION

Lean healthy girls without PCOS to serve as controls for the cardiovascular markers. \*No participants were enrolled in this Arm.

Interventions

rosiglitazone DRUG

4 mg daily for 6 months

Also known as: Avandia

Rosiglitazone

drospirenone/ethinyl estradiol DRUG

1 tab (3mg/30mcg) daily for 6 months

Also known as: Yasmin

Drospirenone/ethinyl estradiol

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 10 - 20 years
• Pubertal level of Tanner stage III-V and menarchal
• BMI percentile for age and sex greater than or equal to 85%ile

You may not qualify if:

• Oral medications for PCOS, or that have impact on bone (i.e. anti-epileptics)
• Presence of other diseases, systemic or psychiatric, or chronic medications which could interfere with endocrine function
• Established diagnosis of diabetes
• Prior bone surgery, prior osteoporotic fracture, or fracture in the past 12 months
• Prior thromboembolic event, such as a deep venous thrombosis or pulmonary embolism (PCOS subjects only)
• Vitamin D deficiency (\<10ng/mL)
• Hyperkalemia (K\>5.0 meq/L)
• Positive pregnancy test (serum)

Sponsors & Collaborators

• Silva Arslanian: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (1)

• Tfayli H, Ulnach JW, Lee S, Sutton-Tyrrell K, Arslanian S. Drospirenone/ethinyl estradiol versus rosiglitazone treatment in overweight adolescents with polycystic ovary syndrome: comparison of metabolic, hormonal, and cardiovascular risk factors. J Clin Endocrinol Metab. 2011 May;96(5):1311-9. doi: 10.1210/jc.2010-2547. Epub 2011 Feb 16.

  PMID: 21325466 RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Rosiglitazone; drospirenone and ethinyl estradiol combination

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

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The potential unblinding due to the rapid regulation of withdrawal bleeding which may have influenced the dropout rates;the short duration of treatment in contrast to clinical practice where treatment may be for several years.

Results Point of Contact

• Title: Dr. Silva Arslanian
• Organization: Children's Hospital of Pittsburgh of UPMC

412-692-6935

Study Officials

• Silva Arslanian, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 21, 2008
• Study Start: March 1, 2005
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 17, 2017
• Results First Posted: November 17, 2017

Record last verified: 2017-10

Locations

US (1)