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A prospective study to determine the metabolic effects of the contraceptive vaginal ring among overweight and obese women with polycystic ovary syndrome (PCOS). We will recruit a total of 40 participants and study use of the vaginal ring over a 4-month period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contraceptive Ring | Experimental | Etonogestrel/ethinyl estradiol vaginal ring (NuvaRing), which releases 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etonogestrel/ethinyl estradiol vaginal ring | Drug | 16 weeks of continuous use of contraceptive vaginal ring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Metabolic Syndrome | Metabolic Syndrome defined according to the updated Adult Treatment Panel III as 3 or more of the following criteria: blood pressure ≥130/85 mm Hg, waist circumference >35 inches, fasting glucose ≥110 mg/dL, TG ≥150 mg/dL, HDL-C <50 mg/dL. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in low-density lipoprotein (LDL) measure | 4 months | |
| Change in high-density lipoprotein (HDL) measure | 4 months | |
| Change in triglycerides measure |
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Inclusion Criteria:
Exclusion Criteria:
Current pregnancy or desire for pregnancy during course of study
Current breastfeeding
Second-trimester pregnancy within four weeks prior to initiation of NuvaRing or third-trimester pregnancy within 6 months prior to initiation of NuvaRing
Use of hormonal contraception within four weeks prior to initiation of NuvaRing
Diagnosis of metabolic syndrome. Metabolic syndrome will be defined according to the updated Adult Treatment Panel III as 3 or more of the following criteria: blood pressure ≥130/85 mm Hg, waist circumference >35 inches, fasting glucose ≥110 mg/dL, TG ≥150 mg/dL, HDL-C <50 mg/dL.
Contraindications to NuvaRing use:
Medical comorbidities:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Roe, MD MPH | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| 4 months |
| Change in apolipoprotein A | 4 months |
| Change in apolipoprotein B | 4 months |
| Change in advanced lipid testing measure | 4 months |
| Change in cholesterol efflux capacity | 4 months |
| Change in fasting insulin level | 4 months |
| Change in fasting 2 hour oral Glucose Tolerance Test result | 4 months |
| Change in Testosterone | 4 months |
| Change in Ferriman-Gallwey Hirsutism score | A lower score indicates less hirsutism. The F-G scoring system has a minimum value of 0, and a maximum value of 36. | 4 months |
| Body Mass Index | 4 months |
| Change in scoring on the Center for Epidemiologic Studies Depression Scale | The range of values is zero to 60, with the higher scores indicating the presence of more depressive symptoms. | 4 months |
| Change in scoring on the State-Trait Anxiety Inventory | The State-Trait Anxiety Inventory measures both state and trait anxiety, the scores range from 20 to 80, with higher scores correlating with greater anxiety. | 4 months |
| Change in scoring on Polycystic Ovary Syndrome Quality of Life Questionnaire | Worse quality of life is associated with a lower score on the questionnaire, with a range score from 30 to 210. | 4 months |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C044815 | etonogestrel |
| C516519 | NuvaRing |
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