- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04257500
Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS (RING-PCOS)
January 22, 2024 updated by: Andrea Roe, MD, MPH
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrea Morley
- Phone Number: 215-615-4202
- Email: Andrea.Morley@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
-
Contact:
- Elizabeth Ruiz
- Email: elizabeth.ruiz@pennmedicine.upenn.edu
-
Principal Investigator:
- Andrea Roe, MD, MPH
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Contraceptive Ring
Etonogestrel/ethinyl estradiol vaginal ring (NuvaRing), which releases 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily.
|
16 weeks of continuous use of contraceptive vaginal ring
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Metabolic Syndrome
Time Frame: 4 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in low-density lipoprotein (LDL) measure
Time Frame: 4 months
|
4 months
|
|
Change in high-density lipoprotein (HDL) measure
Time Frame: 4 months
|
4 months
|
|
Change in triglycerides measure
Time Frame: 4 months
|
4 months
|
|
Change in apolipoprotein A
Time Frame: 4 months
|
4 months
|
|
Change in apolipoprotein B
Time Frame: 4 months
|
4 months
|
|
Change in advanced lipid testing measure
Time Frame: 4 months
|
4 months
|
|
Change in cholesterol efflux capacity
Time Frame: 4 months
|
4 months
|
|
Change in fasting insulin level
Time Frame: 4 months
|
4 months
|
|
Change in fasting 2 hour oral Glucose Tolerance Test result
Time Frame: 4 months
|
4 months
|
|
Change in Testosterone
Time Frame: 4 months
|
4 months
|
|
Change in Ferriman-Gallwey Hirsutism score
Time Frame: 4 months
|
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
|
Body Mass Index
Time Frame: 4 months
|
4 months
|
|
Change in scoring on the Center for Epidemiologic Studies Depression Scale
Time Frame: 4 months
|
The range of values is zero to 60, with the higher scores indicating the presence of more depressive symptoms.
|
4 months
|
Change in scoring on the State-Trait Anxiety Inventory
Time Frame: 4 months
|
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
|
Change in scoring on Polycystic Ovary Syndrome Quality of Life Questionnaire
Time Frame: 4 months
|
Worse quality of life is associated with a lower score on the questionnaire, with a range score from 30 to 210.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrea Roe, MD MPH, 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 Major Dates
Study Start (Actual)
June 24, 2020
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
January 31, 2020
First Submitted That Met QC Criteria
February 5, 2020
First Posted (Actual)
February 6, 2020
Study Record Updates
Last Update Posted (Actual)
January 24, 2024
Last Update Submitted That Met QC Criteria
January 22, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Neoplasms
- Endocrine System Diseases
- Disease
- Ovarian Cysts
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Overnutrition
- Nutrition Disorders
- Body Weight
- Insulin Resistance
- Hyperinsulinism
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Polycystic Ovary Syndrome
- Syndrome
- Metabolic Syndrome
- Overweight
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Hormonal
- Estradiol
- Ethinyl Estradiol
- Etonogestrel
- NuvaRing
Other Study ID Numbers
- 834422
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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