RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-09-03

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04257500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Andrea Morley

CONTACT

215-615-4202

andrea.morley@pennmedicine.upenn.edu

Principal Investigator

Andrea Roe, MD MPH

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Andrea Roe, MD, MPH

Andrea Roe, MD MPH, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-03

Study Completion Date2025-12

Study Record Updates

Study Start Date2020-09-03

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Polycystic Ovary Syndrome