Health TrialsbyHealthPanel

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)

ConditionsRandomizedOpen-labelSafetyTolerabilityPharmacokineticsBacterial Vaginosis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • GenSci142 capsule

    Drug

    Vaginal administration

  • clindamycin phosphate vaginal cream

    Drug

    Clindamycin ointment, 5 grams, once daily for 7 days

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: GenSci142 capsuleExperimental treatment 1 intervention
Group B: clindamycin phosphate vaginal creamActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of treatment-emergent adverse events

Time frame
From the first dose to Day 30

Secondary outcomes

1

Clinical cure rate base on Amsel assessment

Time frame
from first dose of study treatment up to 21~30 days after first dose
2

Change of Nugent score from baseline

Time frame
from first dose of study treatment up to 2 days after first dose
3

Microbiological cure rate base on Nugent score of <4

Time frame
from first dose of study treatment up to 21~30 days after first dose
4

Clinical cure rate base on Amsel assessment

Time frame
from first dose of study treatment up to 8~14 days after first dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changchun GeneScience Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: