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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrea Roe, MD, MPH
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Etonogestrel; NuvaRing; Polyestradiol phosphate

Criteria

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