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The Contraceptive Efficacy and Safety of an Intravaginal Acetic Acid Thermoreversible Gel on Chinese Women.

NCT06203080 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-01-12

No results posted yet for this study

Summary

The study aims to explore the efficacy and safety of an intravaginal acetic acid thermoreversible gel in Chinese women of reproductive age, comparing it with nonoxinol gel by assessing the six-month Pearl Index and the incidence of any side effects.

Conditions

  • Contraceptive Device; Complications

Interventions

DRUG

ancetate gel

An acetic acid thermoreversible gel produced by Shanghai Jinxiang Latex Products Co. will be utilized for the intervention. Each product weighs 4.85 g and contains 54.45 mg of poloxamer 407-acetic acid. The investigators will stockpile the product and distribute a total of 72 doses on the first day, at the end of the second month, and at the end of the fourth month of follow-up, respectively, after concealing the product's name. Participants will receive instructions to apply the medication transvaginally, one dose at a time, during each instance of sexual activity.

DRUG

nonoxinol gel

The nonoxinol gel produced by China Pharmaceutical University Pharmacy Co., Ltd will be utilized for the intervention. Each product weighs 5 g and contains 50 mg of N-9. The investigators will stockpile the product and distribute a total of 72 doses on the first day, at the end of the second month, and at the end of the fourth month of follow-up, respectively, after concealing the product's name. Participants will receive instructions to apply the medication transvaginally, one dose at a time, during each instance of sexual activity.

Sponsors & Collaborators

  • Shanghai Jinxiang Latex Products Co.

    collaborator UNKNOWN

  • National Research Institute for Family Planning, China

    lead OTHER_GOV

Principal Investigators

  • Kaiyan Pei, MD · National Research Institute for Family Planning

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06203080 on ClinicalTrials.gov