Clinical trial NCT02275546: Performance and Safety of Vaginal Ring Applicator in Healthy Females (MK-8342A-063)
Official title: A Multicenter, Open Label, Randomized, Two-period Crossover Study on the Insertion of MK-8342A (NuvaRing®) Placebo With and Without the Use of NuvaRing Applicator in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception: Optional Applicator for Insertion of Vaginal Ring
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the performance and safe use of the vaginal ring applicator as an optional aid for insertion of a placebo vaginal ring into the vagina in healthy women


Eligibility criteria: Inclusion Criteria:

* healthy, non-pregnant, pre-menopausal female who is not using NuvaRing.
* must meet one of the two following criteria: 1) has not taken a combined hormonal contraceptives for at least 3 months prior to screening and has normal predictable menstrual cycles ranging from 26 to 35 days in length with no history of intermenstrual bleeding in the past 6 months; or 2) has been taking a combined hormonal contraceptive for \>3 months and has not experienced unscheduled bleeding for the past 3 months.
* willing to abstain from vaginal penetration, including during sexual intercourse and masturbation, from the time of randomization (Visit 2) to the end of the follow-up period.
* willing to abstain from vaginal penetration with any objects other than the applicator and placebo rings (including but not limited to tampons, douching, use of vaginal applicators for medication, medication, diaphragms, cervical caps, male and female condoms, lubricants, sex toys) from the time of randomization (Visit 2) to the end of the follow-up period.
* good physical and mental health, based upon the medical judgment of the investigator.

Exclusion Criteria:

* current use or has used within past 3 months any of the following: NuvaRing, progestin-only contraceptives (including pills, injection, or implant), oral or transdermal combined hormonal contraceptives with extended or continuous hormonal regimens that prevent monthly withdrawal bleeding by omitting monthly progestin-free intervals. Note: Current use of oral or transdermal combined hormonal contraceptives with 4 to 7 progestin-free days per 28-day cycle for \>3 months is permitted.
* has stopped use of any hormonal contraceptive, including NuvaRing, \<3 months prior to screening; previous use (≥3 months prior to screening) is permitted.
* history of difficulty retaining NuvaRing in the vagina and therefore could not continue on it as a contraceptive method or difficulty retaining other products (e.g., tampons) in the vagina.
* is pregnant or within 2 months of last pregnancy outcome (delivery, spontaneous or induced abortion, medical or surgical management of ectopic pregnancy).
* is breastfeeding.
* diagnosed or treated for a sexually transmitted disease within the past 6 months.
* current complaints of vaginal or vulvar irritation, discomfort, abnormal bleeding/spotting, or abnormal discharge.
* abnormal cervical Pap smear documented within 12 months of screening.
* genital herpes outbreak in the past 3 years.
* has received any investigational drug or device in the 30 days prior to screening and/or plans to receive any investigational drug or device at any time up to the last protocol-required visit.
* known current gynecological disorder which, in the opinion of the investigator, interferes with the objectives of the study.
* known allergy/sensitivity or contraindication to the investigational product (applicator) or ethylene vinyl acetate.
* current or recent history (within the last six months) of drug or alcohol abuse or dependence.

Primary outcomes:
measure: Percentage of Participants With Successful Ring Insertion
timeFrame: Day 1 (immediately after vaginal ring insertion)
measure: Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion
timeFrame: Up to 48 hours after vaginal ring insertion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Feldman R, Frenkl TL, Yacik C, Wang Y, Fox MC. Safety and efficacy of the NuvaRing(R) Applicator in healthy females: a multicenter, open-label, randomized, 2-period crossover study. Contraception. 2016 Oct;94(4):362-5. doi: 10.1016/j.contraception.2016.04.017. Epub 2016 May 17.