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Application for the Etonogestrel/Ethinyl Estradiol Ring (AFTER)

Primary Purpose

Emergency Contraception, Healthy, Reproductive Age Women

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Etonogestrel/ethinyl estradiol contraceptive vaginal ring

About this trial

This is an interventional prevention trial for Emergency Contraception focused on measuring Emergency contraception, Contraceptive vaginal ring, NuvaRing, Contraception

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Keck Medicine of USC--Downtown LARecruiting
LAC+USC Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

12-14mm leading follicle size

15-17mm leading follicle size

18mm or greater leading follicle size

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03120728

First Posted

March 31, 2017

Last Updated

July 13, 2017

Sponsor

University of Southern California

1. Study Identification

Unique Protocol Identification Number

NCT03120728

Brief Title

Application for the Etonogestrel/Ethinyl Estradiol Ring

Acronym

AFTER

Official Title

AFTER: Application for the Etonogestrel/Ethinyl Estradiol Ring--potential for Emergency Contraception

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 10, 2017 (Actual)

Primary Completion Date

June 30, 2018 (Anticipated)

Study Completion Date

July 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

Detailed Description

The study will be comprised of healthy, non-pregnant, non-breastfeeding, reproductive age women with regular, ovulatory cycles who are protected from unintended pregnancy via the concurrent use of non-hormonal methods of contraception. Participants will have a mid-luteal screening visit, which will include: informed consent, history, physical, vitals, and assessment of mid-luteal serum progesterone to confirm ovulatory status. Each participant will be assigned to one of three groups according the size of the leading follicle (12-14mm, 15-17mm, ≥18mm), which will determine the timing of the placement of the ENG/EE CVR. Transvaginal ultrasound (TVUS) will be performed three times per week, starting on day 8 of the menstrual cycle, until the leading follicle is within the assigned group. On that day the CVR will be placed and, including day of placement, there will be 6 daily visits with hormonal assays (progesterone, luteinizing hormone) and TVUS to assess for signs of ovulation. Compliance with CVR placement will be assessed through the measurement of serum ENG. After 7 days, participants will remove the CVR at home. Participants will then have biweekly visits until onset of menses to obtain serum progesterone levels and TVUS to assess for signs of delayed ovulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Emergency Contraception, Healthy, Reproductive Age Women

Keywords

Emergency contraception, Contraceptive vaginal ring, NuvaRing, Contraception

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

12-14mm leading follicle size

Arm Type

Experimental

Arm Description

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

Arm Title

15-17mm leading follicle size

Arm Type

Experimental

Arm Description

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

Arm Title

18mm or greater leading follicle size

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Etonogestrel/ethinyl estradiol contraceptive vaginal ring

Other Intervention Name(s)

NuvaRing, Contraceptive vaginal ring

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of ovulation suppression or dysfunction in relation to follicle size

Description

Time Frame

The outcome is measured throughout the 6 week study.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Blanca Ovalle

Phone

323-409-3104

obgynresearch@med.usc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diana Crabtree Sokol, MD

Organizational Affiliation

University of Southern California

Official's Role

Principal Investigator

Facility Information:

Facility Name

Keck Medicine of USC--Downtown LA

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Blanca Ovalle

Phone

323-409-3104

obgynresearch@med.usc.edu

First Name & Middle Initial & Last Name & Degree

Diana Crabtree Sokol, MD

Facility Name

LAC+USC Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Blanca Ovalle

Phone

323-409-3104

obgynresearch@med.usc.edu

First Name & Middle Initial & Last Name & Degree

Diana Crabtree Sokol, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Application for the Etonogestrel/Ethinyl Estradiol Ring

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