contraception
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
Sponsor study identifier
interventional
240
1 country
4
Study Start
January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2, 2024
Actual (reported)January 12, 2024
Actual (reported)June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Failure rate
Pregnancy due to contraceptive failure under correct use and pregnancy due to incorrect and or discontinuous use will be respectively observed for six months for both groups.
Six months
Pregnancy rate during three months
A cumulative incidence will be calculated according to the number of pregnancies during the first three months.
Three months
Pregnancy rate during six months
A cumulative incidence will be calculated according to the number of pregnancies during the whole six months.
Six months
Termination rate during three months
The termination due to any complications will be observed respectively in both groups during the first three months.
Three months
Termination rate during six months
The termination due to any complications will be observed respectively in both groups during the whole six months.
Six months
Complaint of adverse reactions
Six months
Biochemical index
Six months
Adherence use
Six months
Concomitant drugs
Six months
Vaginal internal environment
Six months
An acetic acid thermoreversible gel developed by Shanghai Jinxiang Latex Products Co. will be allocated to the intervention group.
Nonoxinol gel produced by China Pharmaceutical University Pharmacy Co., Ltd will be allocated to the cotrolled group.
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.
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100081, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050004, China
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200433, China
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, Tianjin Municipality, 300199, China
Kaiyan Pei, MD
National Research Institute for Family Planning, China
First Submitted
January 2, 2024
First Posted
January 12, 2024
Study Start
January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2025
Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients
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.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 12, 2024
Record last verified: 2024-01
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Source: ClinicalTrials.gov.
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