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.
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);
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;
Parallel
ancetate gel
DrugAn 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
DrugThe 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.
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.
Pregnancy rate during three months
A cumulative incidence will be calculated according to the number of pregnancies during the first three months.
Pregnancy rate during six months
A cumulative incidence will be calculated according to the number of pregnancies during the whole 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.
Complaint of adverse reactions
Complaint rates of various adverse reactions (allergy/leucorrhoea/local irritation) during different follow-up time.
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.
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.
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.
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National Research Institute for Family Planning, China
Lead sponsor
Shanghai Jinxiang Latex Products Co.
Collaborator
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