Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/obese Women with PCOS (RING-PCOS)

Andrea Roe, MD, MPH

Status and phase

Enrolling

Phase 4

Conditions

Polycystic Ovary Syndrome

Treatments

Drug: Etonogestrel/ethinyl estradiol vaginal ring

Study type

Interventional

Funder types

Other

Identifiers

NCT04257500

834422

Details and patient eligibility

About

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.

Enrollment

28 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No 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