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NCT06203080
PHASE2

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

Sponsor: National Research Institute for Family Planning, China

View on ClinicalTrials.gov

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.

Official title: The Efficacy and Safety of an Intravaginal Acetic Acid Thermoreversible Gel on Chinese Women of Reproductive Age Compared With Nonoxinol Gel: A Multi-central Phase II, Triple-blind, Randomized Trial

Key Details

Gender

FEMALE

Age Range

20 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-01-01

Completion Date

2026-06-30

Last Updated

2024-01-12

Healthy Volunteers

Yes

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.

Locations (4)

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Tianjin Central Hospital of Gynecology Obstetrics

Tianjin, Tianjin Municipality, China