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

Polycystic Ovary Syndrome Clinical Trial

— RING-PCOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04257500
• Other study ID #: 834422
• Status: Recruiting
• Phase: Phase 4
• Start date: June 24, 2020
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: Andrea Morley
• Phone: 215-615-4202
• Email: andrea.morley[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Overweight
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Etonogestrel/ethinyl estradiol vaginal ring
16 weeks of continuous use of contraceptive vaginal ring

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Andrea Roe, MD, MPH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Metabolic Syndrome	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.	4 months
Secondary	Change in low-density lipoprotein (LDL) measure		4 months
Secondary	Change in high-density lipoprotein (HDL) measure		4 months
Secondary	Change in triglycerides measure		4 months
Secondary	Change in apolipoprotein A		4 months
Secondary	Change in apolipoprotein B		4 months
Secondary	Change in advanced lipid testing measure		4 months
Secondary	Change in cholesterol efflux capacity		4 months
Secondary	Change in fasting insulin level		4 months
Secondary	Change in fasting 2 hour oral Glucose Tolerance Test result		4 months
Secondary	Change in Testosterone		4 months
Secondary	Change in Ferriman-Gallwey Hirsutism score	A lower score indicates less hirsutism. The F-G scoring system has a minimum value of 0, and a maximum value of 36.	4 months
Secondary	Body Mass Index		4 months
Secondary	Change in scoring on the Center for Epidemiologic Studies Depression Scale	The range of values is zero to 60, with the higher scores indicating the presence of more depressive symptoms.	4 months
Secondary	Change in scoring on the State-Trait Anxiety Inventory	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.	4 months
Secondary	Change in scoring on Polycystic Ovary Syndrome Quality of Life Questionnaire	Worse quality of life is associated with a lower score on the questionnaire, with a range score from 30 to 210.	4 months