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

Launched by ANDREA ROE, MD, MPH · Feb 5, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating how the use of a contraceptive vaginal ring affects the health of overweight and obese women who have Polycystic Ovary Syndrome (PCOS). The study is looking to understand if using this form of hormonal birth control can impact the risk of developing metabolic syndrome, which includes issues like high blood pressure, high blood sugar, and high cholesterol. They plan to include 40 women in the study, and each participant will use the vaginal ring for four months.

To participate in this trial, women need to be between 18 and 40 years old, have a confirmed diagnosis of PCOS, and have a body mass index (BMI) between 25 and 45, which indicates they are overweight or obese. Participants should also be in generally good health and willing to avoid pregnancy during the study. However, certain conditions, like being pregnant or breastfeeding, having a history of specific health issues, or recent use of hormonal contraception, will exclude some women from joining. If you qualify and participate, you'll be contributing to important research that could help improve health care for women with PCOS in the future.

Gender

FEMALE

Eligibility 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