Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring and Levonorgestrel-Ethinyl Estradiol Combined Oral Contraceptive in Adult Women at Risk for Pregnancy (MK-8342B-062)

NCT ID: NCT02616146

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 2016 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2016-10-06

Brief Summary

The purpose of this study is to assess the contraceptive efficacy of the etonogestrel + 17β-estradiol (ENG-E2) vaginal ring in women between 18 and 35 years of age based on the number of in-treatment pregnancies as expressed by the Pearl Index (PI). The study will also assess the safety and tolerability of ENG-E2 vaginal ring. The levonorgestrel-ethinyl estradiol (LNG-EE) 150/30 μg combined oral contraceptive (COC) will be used as the active comparator.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ENG-E2 125 μg/300 μg

Participants will receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle will consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.

Group Type: EXPERIMENTAL

ENG-E2 125 μg/300 μg vaginal ring

Intervention Type: DRUG

Up to 13 cycles of ENG-E2 125 μg/300 μg administered intravaginally, each cycle consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.

LNG-EE 150 μg/30 μg

Participants will receive up to 13 cycles of LNG-EE 150 μg/30 μg. Each cycle will consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.

Group Type: ACTIVE_COMPARATOR

LNG-EE 150 μg/30 μg COC

Intervention Type: DRUG

Up to 13 cycles of LNG-EE 150 μg/30 μg administered orally, each cycle consisting of one tablet per day for 21 days, followed a 7-day tablet-free interval.

Interventions

ENG-E2 125 μg/300 μg vaginal ring

Up to 13 cycles of ENG-E2 125 μg/300 μg administered intravaginally, each cycle consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.

Intervention Type: DRUG

LNG-EE 150 μg/30 μg COC

Up to 13 cycles of LNG-EE 150 μg/30 μg administered orally, each cycle consisting of one tablet per day for 21 days, followed a 7-day tablet-free interval.

Intervention Type: DRUG

Other Intervention Names

Etonogestrel + 17β-Estradiol Vaginal Ring; Levonorgestrel-Ethinyl Estradiol COC

Eligibility Criteria

Inclusion Criteria

• Premenopausal female at risk for pregnancy and seeking contraception.
• Willing to use a hormonal contraceptive vaginal ring for up to 13 treatment cycles, and not intending to use any other form of contraception.
• Body mass index (BMI) of ≥18 and <38 kg/m^2.
• In good physical and mental health, based upon the medical judgment of the investigator.
• Willing to adhere to use of vaginal ring and all required trial procedures.

Exclusion Criteria

• Cardiovascular risks and disorders, including history of venous thromboembolic [VTE] events, arterial thrombotic or thromboembolic [ATE] events, transient ischemic attack, angina pectoris, or claudication; at higher risk of VTE events due to recent prolonged immobilization, plans for surgery requiring prolonged immobilization, or a hereditary or acquired predisposition or elevated risk for venous or arterial thrombosis; currently smoking or uses tobacco/nicotine containing products and is ≥35 years of age; uncontrolled or severe hypertension; history of severe dyslipoproteinemia; <35 years of age with a history of migraine with aura or focal neurological symptoms or ≥35 years of age with a history of migraines with or without aura or focal neurologic symptoms; diabetes mellitus with end-organ involvement or >20 years duration; multiple cardiovascular risk factors such as ≥35 years of age, obesity, inadequately controlled hypertension, use of tobacco/ nicotine products, or inadequately controlled diabetes.
• Gastrointestinal disorders, including history of pancreatitis associated with severe hypertriglyceridemia; clinically significant liver disease, including active viral hepatitis or cirrhosis; history of malabsorptive bariatric surgery.
• Other medical disorders, including history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer; any disease that may worsen under hormonal treatment such as disturbances in bile flow, systemic lupus erythematosus, pemphigoid gestationis or idiopathic icterus during previous pregnancy, middle-ear deafness, Sydenham chorea, or porphyria; known allergy/sensitivity or contraindication to the investigational products or their excipients; history of drug or alcohol abuse or dependence.
• Recent, current, or suspected pregnancy; or has not had at least 2 menstrual cycles or has not completed two 28-day cycles of a hormonal contraceptive following a recent pregnancy; or is breastfeeding.
• Gynecologic conditions: has gonorrhea, chlamydia, or trichomonas or symptomatic vaginitis/cervicitis; has abnormal cervical Pap test or positive high-risk human papillomavirus (HPV) test at screening or documented within 3 years of screening; currently using an intrauterine device/intrauterine system (IUD/IUS) or contraceptive implant; within past 6 months has had undiagnosed (unexplained) abnormal vaginal bleeding or any abnormal vaginal bleeding expected to recur during trial; has stage 4 pelvic organ prolapse (1 cm beyond introitus) or lesser degrees of prolapse with history of difficulty retaining tampons, vaginal rings, or other products within vagina.
• Has used investigational drug and/or participated in other clinical trial within past 8 weeks.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

MSD Osterreich GmbH

Vienna, , Austria

Merck Sharp & Dohme

San José, , Costa Rica

Merck Sharp & Dohme

Glostrup Municipality, , Denmark

MSD Finland Oy

Espoo, , Finland

Merck Sharp & Dohme GmbH

Haar, , Germany

MSD Pharma Hungary Kft.

Budapest, , Hungary

MSD Italia S.r.l.

Rome, , Italy

MSD

Mexico City, , Mexico

Merck Sharp & Dohme BV

Haarlem, , Netherlands

MSD Norge A/S

Drammen, , Norway

Merck Sharp & Dohme, Peru S.R.L.

Lima, , Peru

MSD Polska Sp. Z o.o.

Warsaw, , Poland

MSD (Pty) LTD South Africa

Midrand, , South Africa

MSD Sweden

Stockholm, , Sweden

Countries

Austria; Costa Rica; Denmark; Finland; Germany; Hungary; Italy; Mexico; Netherlands; Norway; Peru; Poland; South Africa; Sweden

Other Identifiers

2014-002208-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-1029-006

Identifier Type: OTHER

Identifier Source: secondary_id

8342B-062

Identifier Type: -

Identifier Source: org_study_id