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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2026

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.

Trial Locations (4)

100081

Beijing Shijitan Hospital, Capital Medical University, Beijing

200433

The Obstetrics & Gynecology Hospital of Fudan University, Shanghai

300199

Tianjin Central Hospital of Gynecology Obstetrics, Tianjin

050004

The Second Hospital of Hebei Medical University, Shijiazhuang

All Listed Sponsors
collaborator

Shanghai Jinxiang Latex Products Co.

UNKNOWN

lead

National Research Institute for Family Planning, China

OTHER_GOV