Test Product for Sexually Transmitted Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Essential Access Health, Berkeley, CA
Sexually Transmitted Diseases+1 More
Test Product - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This is a multi-site, double-blind, crossover, randomized phase II study to evaluate the functional performance of a synthetic male condom as compared to a marketed latex condom.

Eligible Conditions

  • Sexually Transmitted Diseases
  • Contraceptive

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.

Week 4
Clinical Breakage Rate
Clinical Complete Slippage Rate
Total Clinical Failure Rate

Trial Safety

Safety Progress

1 of 3

Side Effects for

Group I (Test)
2%Headache
1%Anaemia
1%Pyrexia
0%Asthenia
0%Hyperchlorhydria
0%Vertigo
0%Alanine Aminotransferase increased
0%Asthma
0%Migraine
0%Pain in extremity
0%Tremor
0%Aspartate Aminotransferase increased
0%Gastritis
0%Rhinitis
0%Thrombocytopenia
0%Constipation
0%Abdominal Pain
0%Insomnia
0%Leukocytosis
0%Back pain
0%Nausea
0%Inflammation
0%white blood cells decreased
0%Alkaline phosphatase increased
0%Diarrhoea
0%Vomiting
0%Pain
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT04051710) in the Group I (Test) ARM group. Side effects include: Headache with 2%, Anaemia with 1%, Pyrexia with 1%, Asthenia with 0%, Hyperchlorhydria with 0%.

Trial Design

2 Treatment Groups

Control Product
1 of 2
Test Product
1 of 2
Active Control
Experimental Treatment

600 Total Participants · 2 Treatment Groups

Primary Treatment: Test Product · No Placebo Group · N/A

Test Product
Device
Experimental Group · 1 Intervention: Test Product · Intervention Types: Device
Control Product
Device
ActiveComparator Group · 1 Intervention: Control Product · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Test Product
2017
Completed Phase 3
~2410

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: throughout the study. each participating couple will engage in 8 acts over a 4 week period.
Closest Location: Essential Access Health · Berkeley, CA
2020First Recorded Clinical Trial
2 TrialsResearching Sexually Transmitted Diseases
3 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to use the study products for eight acts of vaginal intercourse within four weeks of study entry.
You do not agree to use any vaginal or sexual lubricant except the product supplied by the study.
You do not agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.