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

Contraceptive Device; Complications Clinical Trial

— contraception  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06203080
• Other study ID #: NRIFP2023027
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: National Research Institute for Family Planning, China
• Contact: Xue Jiang
• Phone: +8618011490663
• Email: 2216949459[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraceptive Device; Complications

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Shijitan Hospital, Capital Medical University	Beijing	Beijing
China	The Obstetrics & Gynecology Hospital of Fudan University	Shanghai	Shanghai
China	The Second Hospital of Hebei Medical University	Shijia Zhuang	Hebei
China	Tianjin Central Hospital of Gynecology Obstetrics	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
National Research Institute for Family Planning, China	Shanghai Jinxiang Latex Products Co.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pregnancy rate during three months	A cumulative incidence will be calculated according to the number of pregnancies during the first three months.	Three months
Primary	Pregnancy rate during six months	A cumulative incidence will be calculated according to the number of pregnancies during the whole six months.	Six months
Primary	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
Primary	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	Complaint of adverse reactions	Complaint rates of various adverse reactions (allergy/leucorrhoea/local irritation) during different follow-up time.	Six months
Secondary	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
Secondary	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
Secondary	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
Secondary	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