Status:
NOT_YET_RECRUITING
The Contraceptive Efficacy and Safety of an Intravaginal Acetic Acid Thermoreversible Gel on Chinese Women.
Lead Sponsor:
National Research Institute for Family Planning, China
Collaborating Sponsors:
Shanghai Jinxiang Latex Products Co.
Conditions:
Contraceptive Device; Complications
Eligibility:
FEMALE
20-45 years
Phase:
PHASE2
Brief 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 P...
Detailed 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 suggest...
Eligibility Criteria
Inclusion
- 1\) Aged between 20 and 45 years old;
- 2\) Regular menstrual cycles (cycle length 25-35 days, menstruation lasting up to 7 days);
- 3\) Have a history of pregnancy with the current partner at least once;
- 4\) Currently engaging in regular sexual activity and planning to do so in the next six months (at least once a week);
- 5\) Have not used hormonal contraceptive methods in the past 3 months;
- 6\) Normal menstrual cycles have resumed after the removal of an intrauterine device;
- 7\) Normal menstrual cycles have resumed after a previous miscarriage;
- 8\) Breastfeeding women with normal menstrual cycles resumed;
- 9\) No apparent gynecological abnormalities confirmed through examination, and normal cervical cytology (Pap smear grade I according to the Bethesda system);
- 10\) Reliance on the investigational drug as the sole contraceptive method during the study period;
- 11\) Willing to participate in this study, adhere to required follow-up visits, and voluntarily sign the informed consent form.
Exclusion
- 1\) Amenorrhoea for more than 1 month, suspected pregnancy;
- 2\) Moderate to severe erosive changes in the cervix;
- 3\) Vaginal cleanliness grade III or above;
- 4\) Trichomonas, fungal vaginitis, and bacterial vaginosis, among other conditions, have not been cured;
- 5\) Uterine prolapse of degree II or above and severe protrusion of the anterior and posterior vaginal walls;
- 6\) Unexplained vaginal bleeding;
- 7\) Genital tract deformities;
- 8\) Malignant tumors of the genital tract;
- 9\) Moderate or severe urinary incontinence;
- 10\) Recurrent urinary tract infections;
- 11\) History of allergy to acetic acid and/or nonoxinol.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06203080
Start Date
January 1 2024
End Date
June 30 2026
Last Update
January 12 2024
Active Locations (4)
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1
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100081
2
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050004
3
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200433
4
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, Tianjin Municipality, China, 300199