NCT04134039

Brief Summary

This investigation is designed to evaluate the performance rate of a polyurethane (PU) condom versus a standard natural rubber latex (NRL) condom.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 9, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

October 11, 2019

Last Update Submit

September 15, 2021

Conditions

Control of PregnancyPrevention of Sexually Transmitted Infections

Outcome Measures

Primary Outcomes (1)

  • Compared clinical failure rate of condom use between the test condom group and the reference condom group

    Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, will be reported by subjects.

    within 2 hours following each coital act for each condom use

Secondary Outcomes (6)

  • Performance (clinical slippage rate) of the Polyurethane (PU) condom

    within 2 hours following each coital act for each condom use

  • Performance (clinical slippage rate) of the Natural Rubber Latex (NRL) condom

    within 2 hours following each coital act for each condom use

  • Performance (clinical breakage rate) of the Polyurethane (PU) condom

    within 2 hours following each coital act for each condom use

  • Performance (clinical breakage rate) of the Natural Rubber Latex (NRL) condom

    within 2 hours following each coital act for each condom use

  • Incidence of treatment-emergent adverse events and adverse device effects, defined in MEDDEV 2.7/3

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Polyurethane (PU) condom

EXPERIMENTAL

Following randomisation each couple will be given one set of 7 condoms as per randomisation schedule. After use of at least 5 condoms, couples will return to the clinic site for collection of their next set of condoms. Each couple will test a maximum of 14 condoms during their participation in the investigation.

Device: Polyurethane (PU) condomDevice: Natural Rubber Latex (NRL) condom

Natural Rubber Latex (NRL) condom

EXPERIMENTAL

Following randomisation each couple will be given one set of 7 condoms as per randomisation schedule. After use of at least 5 condoms, couples will return to the clinic site for collection of their next set of condoms. Each couple will test a maximum of 14 condoms during their participation in the investigation.

Device: Polyurethane (PU) condomDevice: Natural Rubber Latex (NRL) condom

Interventions

Polyurethane (PU) condomDEVICE

A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types.

Natural Rubber Latex (NRL) condomPolyurethane (PU) condom
Natural Rubber Latex (NRL) condomDEVICE

A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types.

Natural Rubber Latex (NRL) condomPolyurethane (PU) condom

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A male and a female subject aged: 18 - 60 years inclusive.
  • All subjects must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months.
  • All couples must be sexually active and agree to have penile-vaginal intercourse with a frequency sufficient to meet protocol requirements (a minimum of 5 coital acts over 4 weeks).
  • The female partner should already be on an established highly effective form of non-barrier contraception, unless post-menopausal.
  • Couples must agree not to use drugs or non-investigational devices that can affect sexual performance.

You may not qualify if:

  • Either partner is or becomes aware of an allergy or sensitivity to the ingredients of the test products, including the test or reference condoms.
  • Either partner has a pre-existing skin condition (severe eczema/ psoriasis) or systemic allergic reactions or as confirmed by the subject and physical examination.
  • Either partner that needs to use condoms for a specific sexually transmitted infection (STI) protection e.g. discordance for Human Immunodeficiency Virus (HIV) or herpes.
  • Subjects that have previous or planned genital surgery, that in the opinion of the Investigator would consider the subject unsuitable to participate in the clinical investigation e.g. laser for abnormal smear.
  • Male partners that have known erectile or ejaculatory dysfunction.
  • A female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness) in the previous 3 months which, in the opinion of the investigator, deems the partner unsuitable for the investigation.
  • Any subject who has clinical symptoms or signs of a sexually transmitted diseases (STD) or HIV/ AIDS or has a previous history of high-risk behaviour as judged by the investigator.
  • Female partner using medication which in the investigator's opinion would affect vaginal mucosal secretion, such as Chlorpheniramine at any time in the 14 days (or 5 half-lives of the drug, whichever is longer) before first condom use.
  • A male partner with abnormal penile anatomy that would, in the opinion of the investigator, affect the ability to keep the condom in place during intercourse.
  • Either partner intends to continue to use antihistamines, anti-inflammatory drugs or pain killers for the duration of the investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

MeSH Terms

Interventions

Condoms

Intervention Hierarchy (Ancestors)

Contraceptive Devices, MaleContraceptive DevicesEquipment and Supplies

Study Officials

  • Unnop Jaisamrarn, MD

    King Chulalongkorn Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Each condom will be individually wrapped in its primary packet then be put in an identical box. All branding will be masked.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The condom types will be tested in a 2-way cross-over design where couples will be randomised to use each of the 2 condom types in a defined order, according to the randomisation schedule.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 21, 2019

Study Start

February 9, 2021

Primary Completion

July 5, 2021

Study Completion

July 5, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)