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The Contraceptive Efficacy and Safety of an Intravaginal Acetic Acid Thermoreversible Gel on Chinese Women.
Sponsor: National Research Institute for Family Planning, China
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
Conditions
Interventions
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.
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