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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorNational Research Institute for Family Planning, China

About this 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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • ancetate gel
  • nonoxinol gel

Treatment groups

240 Participants
are divided into 2 treatment groups

Sponsors and collaborators

National Research Institute for Family Planning, China

Lead sponsor

Shanghai Jinxiang Latex Products Co.

Collaborator