Application for the Etonogestrel/Ethinyl Estradiol Ring

NCT03120728 | Unknown Phase 4 FDA Drug

• 1 other identifier: HS-16-00930
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

This study is enrolling healthy women ages 18-39yo who are not pregnant or breastfeeding, and are not using hormonal birth control. Initial screening visit will include a blood draw to assess if the participant has recently ovulated. If hormone test indicates ovulation occurred, participant will start the study 8 days after the start of their next menstrual period. On this study visit, vaginal ultrasound will be performed to look the ovaries for follicles. Vaginal ultrasound is then performed approximately every 2 days until the dominant follicle has grown into the size group assigned. When this occurs the participant will place the NuvaRing®, inside the vagina and blood will be drawn for hormone levels. Participant will then return daily the next 5 days (total of 6 daily visits) for vaginal ultrasound and blood draw to assess for signs of ovulation. After the 7th day the ring is in the vagina, the participant will remove the ring from her vagina at home. After removal, there will be twice weekly clinic visits for ultrasound and blood draw until menstrual bleeding occurs. At this point, participation in the study is complete. Participants are compensated for their time.

Conditions

Emergency Contraception; Healthy, Reproductive Age Women

Keywords

Emergency contraception; Contraceptive vaginal ring; NuvaRing; Contraception

Outcome Measures

Primary Outcomes (1)

• Percentage of ovulation suppression or dysfunction in relation to follicle size

  Describe the ability of the contraceptive vaginal ring to cause ovulation suppression or dysfunction when placed in the mid and advanced follicular phase. This will be determined via measurement of steroid hormones and assessment of the leading ovarian follicle for signs of rupture after placement of the contraceptive vaginal ring.

  The outcome is measured throughout the 6 week study.

Study Arms (3)

12-14mm leading follicle size

EXPERIMENTAL

Placement of the etonogestrel/ethinyl estradiol contraceptive vaginal ring when leading follicle measures 12-14mm on transvaginal ultrasound.

Drug: Etonogestrel/ethinyl estradiol contraceptive vaginal ring

15-17mm leading follicle size

EXPERIMENTAL

Placement of the etonogestrel/ethinyl estradiol contraceptive vaginal ring when leading follicle measures 15-17mm on transvaginal ultrasound.

Drug: Etonogestrel/ethinyl estradiol contraceptive vaginal ring

18mm or greater leading follicle size

EXPERIMENTAL

Placement of the etonogestrel/ethinyl estradiol contraceptive vaginal ring when leading follicle measures 18mm or greater on transvaginal ultrasound.

Drug: Etonogestrel/ethinyl estradiol contraceptive vaginal ring

Interventions

Etonogestrel/ethinyl estradiol contraceptive vaginal ring DRUG

Placement of a contraceptive vaginal ring with subsequent assessment of ovulation disruption. Timing of placement depends on leading follicle size, as described in "Arms" section.

Also known as: NuvaRing, Contraceptive vaginal ring

12-14mm leading follicle size; 15-17mm leading follicle size; 18mm or greater leading follicle size

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, women ages 18 to 39yo with BMI \<30
• Regular menstrual cycles with duration between 24-35 days
• Completion of screening visit where ovulation will be assessed with blood draw for progesterone level (must be 5ng/mL or greater)
• Not seeking pregnancy during the study period
• Use of a non-hormonal form of contraception, such as: sterilization (tubal ligation, Essure), copper IUD (intrauterine device), barrier methods or abstinence
• Must speak English or Spanish

You may not qualify if:

• Currently pregnant or breastfeeding
• Severe pelvic organ prolapse or prolapse to any degree that may prevent retention of the vaginal ring after insertion
• Use of oral contraceptive pills, patches, implants or hormonal intrauterine contraception in the month prior to screening
• Use of depo medroxyprogesterone within 6 months of screening
• Use of medications that interact with contraceptive steroid hormones: anti-epileptic medications, rifampin, rifabutin, fosamprenavir, etc
• Medical condition with safety deemed to be category 3 or 4 when using a combined hormonal contraceptive, as determined by the Center for Disease Control Medical Eligibility Criteria: current or past history of breast cancer, severe decompensated cirrhosis, history of deep vein thrombosis or pulmonary embolus, diabetes with nephropathy/retinopathy/neuropathy or other vascular disease diagnosed more than 20 years ago, current symptomatic gallbladder disease, hypertension, ischemic heart disease, known thrombogenic mutations, hepatocellular adenoma, malignant hepatoma, multiple risk factors for atherosclerotic cardiovascular disease, multiple sclerosis with prolonged immobility, history of peripartum cardiomyopathy, cigarette smoking and ≥35yo, history of complicated solid organ transplant, history of stroke, history of superficial venous thrombosis not associated with catheter, systemic lupus erythematosus with positive antiphospholipid antibodies, valvular heart disease complicated by pulmonary hypertension or atrial fibrillation or bacterial endocarditis, and acute viral hepatitis

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (2)

Keck Medicine of USC--Downtown LA

Los Angeles, California, 90017, United States

RECRUITING

LAC+USC Medical Center

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Interventions

etonogestrel; NuvaRing

Study Officials

• Diana Crabtree Sokol, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Blanca Ovalle

CONTACT

323-409-3104; obgynresearch@med.usc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 19, 2017
• Study Start: July 10, 2017
• Primary Completion: June 30, 2018
• Study Completion: July 1, 2018
• Last Updated: July 18, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)