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

Contraceptive Device; Complications Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Despite significant increases in the availability and effectiveness of contraceptives globally, there are few female-led devices that combine contraception and STI prevention. Previous studies suggested that acetic acid thermoreversible gel, a female targeted contraception, can regulate intravaginal ph, killing sperm and STI pathogens and protecting intravaginal probiotics. Therefore, we have developed a contraceptive gel containing 11.23 mg/g of poloxamer 407-acetic acid. To determine its contraceptive effectiveness and safety compared with the widely used nonoxinol gel, we will recruit about 240 reproductive-aged women in four centers in China and randomly allocate into two groups. During a six-month follow-up, we will compared their pregnant rates and incidence of adverse events. ;

Related Conditions & MeSH terms

• Contraceptive Device; Complications

• NCT number: NCT06203080
• Study type: Interventional
• Source: National Research Institute for Family Planning, China
• Contact: Xue Jiang
• Phone: +8618011490663
• Email: 2216949459@qq.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2024
• Completion date: June 30, 2026