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

NCT ID: NCT06203080

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-06-30

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 Pearl Index and the incidence of any side effects.

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 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.

Conditions

Contraceptive Device; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Intervention group

An acetic acid thermoreversible gel developed by Shanghai Jinxiang Latex Products Co. will be allocated to the intervention group.

Group Type: EXPERIMENTAL

ancetate gel

Intervention Type: DRUG

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.

Controlled group

Nonoxinol gel produced by China Pharmaceutical University Pharmacy Co., Ltd will be allocated to the cotrolled group.

Group Type: ACTIVE_COMPARATOR

nonoxinol gel

Intervention Type: DRUG

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.

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Jinxiang Latex Products Co.

UNKNOWN

Sponsor Role: collaborator

National Research Institute for Family Planning, China

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kaiyan Pei, MD

Role: PRINCIPAL_INVESTIGATOR

National Research Institute for Family Planning

Locations

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

Countries

China

Central Contacts

Xue Jiang

Role: CONTACT

2216949459@qq.com

+8618011490663

Facility Contacts

Wenpei Bai, MD

Role: primary

bwp66@163.com

Other Identifiers

NRIFP2023027

Identifier Type: -

Identifier Source: org_study_id