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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Contraceptive Device; Complications
• Intervention / Treatment: Drug: ancetate gel; Drug: nonoxinol gel

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xue Jiang; Phone Number: +8618011490663; Email: 2216949459@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100081
      • Beijing Shijitan Hospital, Capital Medical University
      • Contact: Wenpei Bai, MD; Email: bwp66@163.com
  • Hebei
    • Shijia Zhuang, Hebei, China, 050004
      • The Second Hospital of Hebei Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • The Obstetrics & Gynecology Hospital of Fudan University
  • Tianjin
    • Tianjin, Tianjin, China, 300199
      • Tianjin Central Hospital of Gynecology Obstetrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; An acetic acid thermoreversible gel developed by Shanghai Jinxiang Latex Products Co. will be allocated to the intervention group.	Drug: 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.
Active Comparator: Controlled group; Nonoxinol gel produced by China Pharmaceutical University Pharmacy Co., Ltd will be allocated to the cotrolled group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complaint of adverse reactions	Complaint rates of various adverse reactions (allergy/leucorrhoea/local irritation) during different follow-up time.	Six months
Biochemical index	Biochemical index will be recorded respectively at the beginning of the follow-up and at the end of the follow-up through blood routine, urinalysis and liver function test.	Six months
Adherence use	Adherence use will be evaluated during the follow-up respectively at the end of the first two weeks, two months, four months and six months through checking the number of used drugs packages and unused drugs.	Six months
Concomitant drugs	Concomitant drugs will be recorded during the follow-up respectively at the end of the first two weeks, two months, four months and six months through the questionnaire.	Six months
Vaginal internal environment	Vaginal microbiota examination will be used during the follow-up respectively at the end of the first two weeks, two months, four months and six months by professional physicians to evaluate the participant's vaginal internal environment whether is suitable for continuation of the trial.	Six months

Collaborators and Investigators

• Sponsor: National Research Institute for Family Planning, China
• Collaborators: Shanghai Jinxiang Latex Products Co.
• Investigators: Principal Investigator: Kaiyan Pei, MD, National Research Institute for Family Planning

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: contraception, STD
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents, Male; Spermatocidal Agents; Antispermatogenic Agents; Nonoxynol
• Other Study ID Numbers: NRIFP2023027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No