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

January 2, 2024 updated by: National Research Institute for Family Planning, China

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100081
        • Beijing Shijitan Hospital, Capital Medical University
        • Contact:
    • Hebei
      • Shijia Zhuang, Hebei, China, 050004
        • The Second Hospital of Hebei Medical University
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • The Obstetrics & Gynecology Hospital of Fudan University
    • Tianjin
      • Tianjin, Tianjin, China, 300199
        • Tianjin Central Hospital of Gynecology Obstetrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
An acetic acid thermoreversible gel developed by Shanghai Jinxiang Latex Products Co. will be allocated to the intervention group.
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.
Active Comparator: Controlled group
Nonoxinol gel produced by China Pharmaceutical University Pharmacy Co., Ltd will be allocated to the cotrolled group.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Failure rate
Time Frame: Six months
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
Pregnancy rate during three months
Time Frame: Three months
A cumulative incidence will be calculated according to the number of pregnancies during the first three months.
Three months
Pregnancy rate during six months
Time Frame: Six months
A cumulative incidence will be calculated according to the number of pregnancies during the whole six months.
Six months
Termination rate during three months
Time Frame: Three months
The termination due to any complications will be observed respectively in both groups during the first three months.
Three months
Termination rate during six months
Time Frame: Six months
The termination due to any complications will be observed respectively in both groups during the whole six months.
Six months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complaint of adverse reactions
Time Frame: Six months
Complaint rates of various adverse reactions (allergy/leucorrhoea/local irritation) during different follow-up time.
Six months
Biochemical index
Time Frame: Six months
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
Adherence use
Time Frame: Six months
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
Concomitant drugs
Time Frame: Six months
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
Vaginal internal environment
Time Frame: Six months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Research Institute for Family Planning, China

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Jinxiang Latex Products Co.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kaiyan Pei, MD, National Research Institute for Family Planning

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NRIFP2023027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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