Clinical trial NCT06203080: The Contraceptive Efficacy and Safety of an Intravaginal Acetic Acid Thermoreversible Gel on Chinese Women.
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Contraceptive Device; Complications
Keywords: contraception, STD
Lead sponsor: National Research Institute for Family Planning, China
Sponsor class: OTHER_GOV
Collaborators: name: Shanghai Jinxiang Latex Products Co.
First posted: 2024-01-12
Enrollment: 240
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Failure rate
timeFrame: Six months
measure: Pregnancy rate during three months
timeFrame: Three months
measure: Pregnancy rate during six months
timeFrame: Six months
measure: Termination rate during three months
timeFrame: Three months
measure: Termination rate during six months
timeFrame: Six months
Secondary outcomes:
measure: Complaint of adverse reactions
timeFrame: Six months
measure: Biochemical index
timeFrame: Six months
measure: Adherence use
timeFrame: Six months
measure: Concomitant drugs
timeFrame: Six months
measure: Vaginal internal environment
timeFrame: Six months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital, Capital Medical University
state: Beijing
city: Shijia Zhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Shanghai
country: China
facility: The Obstetrics & Gynecology Hospital of Fudan University
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Central Hospital of Gynecology Obstetrics
state: Tianjin
Study officials:
affiliation: National Research Institute for Family Planning
name: Kaiyan Pei, MD
role: PRINCIPAL_INVESTIGATOR
References: