A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, T… (NCT07663838) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
China30 participantsStarted 2026-06-15
Plain-language summary
A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial vaginosis (BV).
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Women of childbearing age aged 18-50 years (inclusive of the cut-off values, as of the date of signing the informed consent form), with a history of sexual activity and a regular menstrual cycle (21-35 days, inclusive of the cut-off values);
. Screening visits were conducted for women clinically diagnosed with bacterial vaginosis who had not received any treatment for bacterial vaginosis since the onset of their current symptoms. The clinical diagnostic criteria for bacterial vaginosis are as follows:
. At least one clinical symptom (itching, odour, abnormal vaginal discharge),
. and at least three positive findings on the Amsel clinical assessment (with clue cells constituting more than 20% of the total vaginal epithelial cells being a mandatory criterion),
. and a Nugent score of ≥7;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of treatment-emergent adverse events
. Trial participants must agree to abstain from sexual intercourse for 48 hours prior to the first administration of the investigational medicinal product, throughout the treatment period, and for 48 hours prior to each return visit;
. be willing to use vaginal administration and agree to avoid the use of any vaginal products not specified in the trial protocol (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) throughout the trial period;
. Trial participants must voluntarily sign a written informed consent form prior to the trial;
Exclusion criteria
. Those currently suffering from any acute infection of the urinary or reproductive system, including but not limited to pelvic inflammatory disease, cervicitis, endometritis, and adnexitis;
. Those currently suffering from vulvovaginitis caused by other pathogens, including but not limited to Aerobic vaginitis, vulvovaginal candidiasis, trichomoniasis, gonorrhoea, genital herpes, and genital warts;
. Current presence of other vaginal or vulvar conditions, or being in the recovery phase following reproductive system surgery, where the investigator considers this to affect the trial evaluation;
. Patients currently receiving, or who will require during the trial, medications that reduce or antagonise oestrogen levels, such as gonadotropin-releasing hormoneagonists, high-potency progestogens and combined oral contraceptives;
. Patients with a history of or currently suffering from major diseases such as cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine or psychiatric disorders, where the investigator considers inclusion inappropriate;
. Women who are pregnant, breastfeeding, or have tested positive for pregnancy; or those planning to become pregnant during the trial; or those unable to use reliable contraception during the study;
. Individuals with impaired immunity or immune dysfunction, including but not limited to those currently undergoing treatment for malignant tumours, those with autoimmune diseases, or those currently using immunosuppressants;
. Participants with abnormal uterine bleeding, including prolonged menstrual periods (\>7 days);