Performance and Safety of Vaginal Ring Applicator in Healthy Females (MK-8342A-063)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02275546
• Collaborator: (none)
• Enrollment: 164
• Arms: 2
• Actual Duration (Months): 3.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Contraception: Optional Applicator for Insertion of Vaginal Ring	Drug: Placebo vaginal ring; Device: Single-use, non-sterile applicator	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 164 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 11, 2014
• Actual Primary Completion Date: Apr 10, 2015
• Actual Study Completion Date: Apr 10, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Applicator→No Applicator (manual) Treatment period 1: Participants will use applicator to insert vaginal ring. Treatment period 2: Participants will manually insert vaginal ring using fingers only.	Drug: Placebo vaginal ring; Drug-free placebo vaginal ring; Other Names: NuvaRing ; Device: Single-use, non-sterile applicator; Single-use, non-sterile, plastic applicator for insertion of vaginal ring.; Other Names: NuvaRing Applicator
Experimental: No applicator (manual)→Applicator Treatment period 1: Participants will manually insert vaginal ring using fingers only. Treatment period 2: Participants will use applicator to insert vaginal ring.	Drug: Placebo vaginal ring; Drug-free placebo vaginal ring; Other Names: NuvaRing ; Device: Single-use, non-sterile applicator; Single-use, non-sterile, plastic applicator for insertion of vaginal ring.; Other Names: NuvaRing Applicator

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Successful Ring Insertion [Day 1 (immediately after vaginal ring insertion)]

   Participants completed a Post-Insertion Questionnaire in which they were asked about their experience inserting the vaginal ring. Their answers were recorded and evaluated.

2. Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion [Up to 48 hours after vaginal ring insertion]

   Participants completed a Follow-Up Questionnaire in which they asked if they experienced vaginal ring expulsion. Their answers were recorded and evaluated.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Director, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT02275546
• Other Study ID Numbers: 8342A-063
• First Posted: Oct 27, 2014
• Last Update Posted: Feb 4, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: NuvaRing; Ethinyl Estradiol; Desogestrel

Study Results

Participant Flow

Arm/Group Title	Applicator→No Applicator (Manual)	No Applicator (Manual)→Applicator
Arm/Group Description	In Treatment Period 1, participants used the applicator to insert the vaginal ring. In Treatment Period 2 participants manually inserted the vaginal ring using their fingers only.	In Treatment Period 1, participants manually inserted the vaginal ring using their fingers only. In Treatment Period 2, participants used the applicator to insert the vaginal ring.
Period Title: Treatment Period 1
STARTED	81	83
COMPLETED	81	83
NOT COMPLETED	0	0
Period Title: Treatment Period 1
STARTED	81	83
COMPLETED	79	81
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	All Randomized Participants
Arm/Group Description
Overall Participants	164
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	30.2 (6.8)
Sex: Female, Male (Count of Participants)
Female	164 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Successful Ring Insertion
Description	Participants completed a Post-Insertion Questionnaire in which they were asked about their experience inserting the vaginal ring. Their answers were recorded and evaluated.
Time Frame	Day 1 (immediately after vaginal ring insertion)

Outcome Measure Data

Analysis Population Description

Per Protocol Population, which excluded participants due to important deviations from the protocol that could have substantially affected the results of the efficacy endpoints.

Arm/Group Title	Applicator	No Applicator (Manual)
Arm/Group Description	Participants used the applicator to insert the vaginal ring.	Participants manually inserted the vaginal ring using their fingers only.
Measure Participants	102	102
Number (95% Confidence Interval) [Percentage of participants]	100 61%	100 NaN

2. Primary Outcome

Title	Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion
Description	Participants completed a Follow-Up Questionnaire in which they asked if they experienced vaginal ring expulsion. Their answers were recorded and evaluated.
Time Frame	Up to 48 hours after vaginal ring insertion

Outcome Measure Data

Analysis Population Description

Per Protocol Population, which excluded participants due to important deviations from the protocol that could have substantially affected the results of the efficacy endpoints.

Arm/Group Title	Applicator	No Applicator (Manual)
Arm/Group Description	Participants used the applicator to insert the vaginal ring.	Participants manually inserted the vaginal ring using their fingers only.
Measure Participants	102	102
Number (95% Confidence Interval) [Percentage of participants]	0 0%	0 NaN

Adverse Events

Time Frame	Up to 96 hours after vaginal ring insertion
Adverse Event Reporting Description	The safety analysis was based on the All Subjects as Treated (ASaT) Population, which consisted of all randomized participants who attempted to insert a vaginal ring in Treatment Period 1.
Arm/Group Title	Applicator		No Applicator (Manual)
Arm/Group Description	Participants used the applicator to insert the vaginal ring.		Participants manually inserted the vaginal ring using their fingers only.
All Cause Mortality
	Applicator		No Applicator (Manual)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Applicator		No Applicator (Manual)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/163 (0%)		0/162 (0%)
Other (Not Including Serious) Adverse Events
	Applicator		No Applicator (Manual)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/163 (0%)		0/162 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.