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

NCT06203080 | Not Yet Recruiting Phase 2

• 1 other identifier: NRIFP2023027
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

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.

Conditions

Contraceptive Device; Complications

Keywords

contraception, STD

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (5)

• Complaint of adverse reactions

  Six months

• Biochemical index

  Six months

• Adherence use

  Six months

• Concomitant drugs

  Six months

• Vaginal internal environment

  Six months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Drug: ancetate gel

Controlled group

ACTIVE COMPARATOR

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

Drug: nonoxinol gel

Interventions

ancetate gel 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.

Intervention group

nonoxinol gel 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.

Controlled group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) Aged between 20 and 45 years old;
• \) Regular menstrual cycles (cycle length 25-35 days, menstruation lasting up to 7 days);
• \) Have a history of pregnancy with the current partner at least once;
• \) Currently engaging in regular sexual activity and planning to do so in the next six months (at least once a week);
• \) Have not used hormonal contraceptive methods in the past 3 months;
• \) Normal menstrual cycles have resumed after the removal of an intrauterine device;
• \) Normal menstrual cycles have resumed after a previous miscarriage;
• \) Breastfeeding women with normal menstrual cycles resumed;
• \) No apparent gynecological abnormalities confirmed through examination, and normal cervical cytology (Pap smear grade I according to the Bethesda system);
• \) Reliance on the investigational drug as the sole contraceptive method during the study period;
• \) Willing to participate in this study, adhere to required follow-up visits, and voluntarily sign the informed consent form.

You may not qualify if:

• \) Amenorrhoea for more than 1 month, suspected pregnancy;
• \) Moderate to severe erosive changes in the cervix;
• \) Vaginal cleanliness grade III or above;
• \) Trichomonas, fungal vaginitis, and bacterial vaginosis, among other conditions, have not been cured;
• \) Uterine prolapse of degree II or above and severe protrusion of the anterior and posterior vaginal walls;
• \) Unexplained vaginal bleeding;
• \) Genital tract deformities;
• \) Malignant tumors of the genital tract;
• \) Moderate or severe urinary incontinence;
• \) Recurrent urinary tract infections;
• \) History of allergy to acetic acid and/or nonoxinol.

Sponsors & Collaborators

• National Research Institute for Family Planning, China: lead
• Shanghai Jinxiang Latex Products Co.: collaborator

Study Sites (4)

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100081, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050004, China

Location

The Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200433, China

Location

Tianjin Central Hospital of Gynecology Obstetrics

Tianjin, Tianjin Municipality, 300199, China

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kaiyan Pei, MD

  National Research Institute for Family Planning

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xue Jiang

CONTACT

+8618011490663; 2216949459@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 12, 2024
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)