A PHASE 3, RANDOMIZED, ACTIVE-COMPARATOR CONTROLLED CLINICAL TRIAL TO STUDY THE CONTRACEPTIVE EFFICACY AND SAFETY OF THE MK-8342B (ETONOGESTREL + 17β-ESTRADIOL) VAGINAL RING AND THE LEVONORGESTREL-ETHINYL ESTRADIOL (LNG-EE) 150/30 μG COMBINED ORAL CONTRACEPTIVE (COC) IN HEALTHY WOMEN 18 YEARS OF AGE AND OLDER, AT RISK FOR PREGNANCY.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-063-15

Enrollment

Registered

2016-03-29

Start date

2016-03-11

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

At V2, subjects who continue to meet all the enrollment criteria will be randomized to treatment with either the etonogestrel (ENG) 125 + 17&#946

-estradiol (E2) 300 &#956

g /day (herein referred to as ENG-E2) vaginal ring or to the active control, which is the combined oral contraceptive (COC) containing levonorgestrel-ethinyl estradiol (LNG-EE) 150/30 &#956

g. Subjects will be randomized in a 3:1 ratio to the ENG-E2 vaginal ring or the LNG-EE &#956

g COC, respectively. Subjects randomized to ENG-E2 vaginal ring, will be instructed to leave the ring in for 21 days followed by a 7-day ring-free interval prior to inserting the next new ring.

Eligibility

Sex/Gender

Female

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1 Written informed consent for the trial. 2 Premenopausal female, ≥ 18 years old at enrollment. 3 Risk for pregnancy. 4 Willing to use either the ENG-E2 contraceptive vaginal ring or the LNG-EE COC for up to 13 treatment cycles, and not intending to use any other form of contraception for the duration of her participation following randomization at V2. 5 Body mass index (BMI) of ≥18 and <38 kg/m2. Trial sites may exclude subjects with a maximum BMI less than 38 kg/m2 based on local standard of care guidelines for the use of combined hormonal contraceptives. 6 Good physical and mental health, based upon the medical judgment of the investigator. 7 Able and willing to adhere to use of the ENGE2 vaginal ring or LNG-EE COC and to all required trial procedures, including trial visits and use of daily diaries, and does not plan to relocate during the trial.

Exclusion criteria

Exclusion criteria: 1 Cardiovascular disorders. 2 High risk of cardiovascular disorders and other medical conditions. 4 Severe hypertension. 5 Severe dyslipoproteinemia. 6 History of migraine. 7 Diabetes mellitus. 8 Multiple cardiovascular risk factors. 9 Has a history of pancreatitis associated with severe hypertriglyceridemia. 10 Liver disease. 11 Malabsorptive bariatric surgery. 12 Malignancy ≤5 years prior to V1. 13 Any disease that may worsen under hormonal treatment. 14 Allergy/sensitivity to study drug. 15 Drug or alcohol abuse or dependence. 16 Abnormal laboratory result. 17 Any condition that expose the subject to risk by participating in the trial. 18 Pregnancy. 19 At least 2 menstrual cycles following a recent pregnancy. 20 Breastfeeding. 21 Gonorrhea, chlamydia, or trichomonas or symptomatic vaginitis/cervicitis. 22 Abnormal cervical smear or + HPV test. 23 IUD/IUS or contraceptive implant. 24 Abnormal vaginal bleeding. 25 Stage 4 pelvic organ prolapse. 26 Is or has an immediate family member who is part of the site or sponsor staff directly involved with this trial. 27 Used an investigational drug and/or participated in any other clinical trial or has/planned to receive any prohibited medication.

Countries

Austria, Brazil, Chile, Colombia, Czech Republic, Denmark, Finland, Germany, Guatemala, Hungary, Italy, Mexico, Netherlands, Norway, Peru, Poland, Russian Federation, South Africa, Spain, Sweden

Contacts

Public ContactNelva Garcia

MERCK SHARP & DOHME PERU S.R.L

nelva.garcia@merck.com4115187

Outcome results