RING-PCOS: Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS

Sponsor

Andrea Roe, MD, MPH (Other)

Overall Status

Recruiting

CT.gov ID

NCT04257500

Collaborator

(none)

Enrollment

Location

Arm

29.2

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Etonogestrel/ethinyl estradiol vaginal ring	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS

Actual Study Start Date :

Jun 24, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Contraceptive Ring Etonogestrel/ethinyl estradiol vaginal ring (NuvaRing), which releases 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily.	Drug: Etonogestrel/ethinyl estradiol vaginal ring 16 weeks of continuous use of contraceptive vaginal ring Other Names: NuvaRing

Arm

Intervention/Treatment

Experimental: Contraceptive Ring

Etonogestrel/ethinyl estradiol vaginal ring (NuvaRing), which releases 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily.

Drug: Etonogestrel/ethinyl estradiol vaginal ring

16 weeks of continuous use of contraceptive vaginal ring

Other Names:

NuvaRing

Outcome Measures

Primary Outcome Measures

Incidence of Metabolic Syndrome [4 months]
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.

Secondary Outcome Measures

Change in low-density lipoprotein (LDL) measure [4 months]
Change in high-density lipoprotein (HDL) measure [4 months]
Change in triglycerides measure [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 [4 months]
A lower score indicates less hirsutism. The F-G scoring system has a minimum value of 0, and a maximum value of 36.
Body Mass Index [4 months]
Change in scoring on the Center for Epidemiologic Studies Depression Scale [4 months]
The range of values is zero to 60, with the higher scores indicating the presence of more depressive symptoms.
Change in scoring on the State-Trait Anxiety Inventory [4 months]
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.
Change in scoring on Polycystic Ovary Syndrome Quality of Life Questionnaire [4 months]
Worse quality of life is associated with a lower score on the questionnaire, with a range score from 30 to 210.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of PCOS according to Rotterdam criteria, with at least 2 of 3 of the following criteria: oligomenorrhea (≤8 periods per year), clinical or biochemical hyperandrogenism, and polycystic ovaries on ultrasound
Body mass index ≥25 and ≤45 kg/m2
In good general health according to the investigators' discretion
Willing to avoid pregnancy for the duration of the study

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:
Age ≥ 35 plus tobacco use
Current or past deep vein thrombosis or pulmonary embolism
Cerebrovascular disease
Coronary artery disease
Thrombogenic valvular or rhythm diseases of the heart (such as subacute bacterial endocarditis with valvular disease or atrial fibrillation)
Inherited or acquired coagulopathy
Headaches with focal neurological symptoms or migraine headaches with aura
Age ≥ 35 plus any migraine headaches
Liver tumors, benign or malignant
Undiagnosed abnormal uterine bleeding
Current or past breast cancer or other estrogen- or progestin-sensitive cancer
Hypersensitivity to any of the components of NuvaRing
Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir
Medical comorbidities:
21-hydroxylase deficiency, congenital adrenal hyperplasia
Untreated thyroid disease
Untreated hyperprolactinemia
Type 1 or 2 diabetes mellitus
Uncontrolled liver disease
Uncontrolled renal disease
Current alcohol abuse
Hypertension ≥ 140 mm Hg average systolic or ≥ 90 mm Hg average diastolic in women using anti-hypertensive medication
Hypertension ≥ 150 mm Hg average systolic or ≥ 100 mm Hg average diastolic in women not using anti-hypertensive medication
History of or current gynecologic cancer
Triglycerides >=250 mg/dL
Current use of lipid-lowering or weight loss agents
Participation in any study of an investigational drug or device or biologic agent within 30 days
Suspected adrenal or ovarian tumor secreting androgens
Suspected Cushing's syndrome
Bariatric surgery within 12 months
Other medical concerns that in the judgment of the investigator may compromise safety of the participant or confound the reliability of compliance and information acquired in this study