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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
240
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.
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.
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
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.
Time frame: Six months
Pregnancy rate during three months
A cumulative incidence will be calculated according to the number of pregnancies during the first three months.
Time frame: Three months
Pregnancy rate during six months
A cumulative incidence will be calculated according to the number of pregnancies during the whole six months.
Time frame: 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.
Time frame: 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.
Time frame: Six months
Complaint of adverse reactions
Complaint rates of various adverse reactions (allergy/leucorrhoea/local irritation) during different follow-up time.
Time frame: 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.
Time frame: Six months
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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.
Time frame: 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.
Time frame: 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.
Time frame: Six months