Clinical trial NCT04257500: Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/obese Women with PCOS
Official title: Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/obese Women with PCOS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


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

Primary outcomes:
measure: Incidence of Metabolic Syndrome
timeFrame: 4 months
Secondary outcomes:
measure: Change in low-density lipoprotein (LDL) measure
timeFrame: 4 months
measure: Change in high-density lipoprotein (HDL) measure
timeFrame: 4 months
measure: Change in triglycerides measure
timeFrame: 4 months
measure: Change in apolipoprotein A
timeFrame: 4 months
measure: Change in apolipoprotein B
timeFrame: 4 months
measure: Change in advanced lipid testing measure
timeFrame: 4 months
measure: Change in cholesterol efflux capacity
timeFrame: 4 months
measure: Change in fasting insulin level
timeFrame: 4 months
measure: Change in fasting 2 hour oral Glucose Tolerance Test result
timeFrame: 4 months
measure: Change in Testosterone
timeFrame: 4 months
measure: Change in Ferriman-Gallwey Hirsutism score
timeFrame: 4 months
measure: Body Mass Index
timeFrame: 4 months
measure: Change in scoring on the Center for Epidemiologic Studies Depression Scale
timeFrame: 4 months
measure: Change in scoring on the State-Trait Anxiety Inventory
timeFrame: 4 months
measure: Change in scoring on Polycystic Ovary Syndrome Quality of Life Questionnaire
timeFrame: 4 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Andrea Roe, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: