UnknownPhase 3

A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Recurrent Vulvovaginal Candidiasis

China196 participantsStarted 2021-09-14

Plain-language summary

The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 capsule In Subjects With Recurrent Vulvovaginal Candidiasis

Age range18 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Females, ≥18 and ≤75 years old.
✓. Have a history of RVVC at screening.
✓. Suitable for oral therapy and able to swallow capsules intact.
✓. Subjects of childbearing potential must use highly effective contraceptive measures throughout the study.
✓. Willing to sign the informed consent form to participate in this study.

✕. Presence of concomitant vulvovaginitis caused by other pathogens.
✕. Have a history of cervical cancer, or "cervical intraepithelial neoplasia or malignancy" or "atypical squamous cells of undetermined significance (ASCUS)" as indicated by Pap test or other tests reported within 1 year before screening (not applicable to subjects with a history of total hysterectomy).
✕. Any condition that, in the opinion of the investigator, could impact drug absorption, distribution, or elimination.
✕. Moderate to severe hepatic and/or renal disorders.
✕. Significant laboratory abnormality at screening.
✕. QTc interval greater than 470 ms or other clinically significant ECG abnormality at screening.
✕. Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, and vulvovaginal corticosteroids within 7 days prior to randomization.
✕. Have received any estrogen replacement therapy or vaginal topical products.

The proportion of subjects with one or more culture-verified VVC episodes during the study.

Timeframe: 50 weeks

NCT IDNCT05074602

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-30

Yong Cao, M.D

Who can participate

Age range18 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Females, ≥18 and ≤75 years old.
✓. Have a history of RVVC at screening.
✓. Suitable for oral therapy and able to swallow capsules intact.
✓. Subjects of childbearing potential must use highly effective contraceptive measures throughout the study.
✓. Willing to sign the informed consent form to participate in this study.

✕. Presence of concomitant vulvovaginitis caused by other pathogens.
✕. Have a history of cervical cancer, or "cervical intraepithelial neoplasia or malignancy" or "atypical squamous cells of undetermined significance (ASCUS)" as indicated by Pap test or other tests reported within 1 year before screening (not applicable to subjects with a history of total hysterectomy).
✕. Any condition that, in the opinion of the investigator, could impact drug absorption, distribution, or elimination.
✕. Moderate to severe hepatic and/or renal disorders.
✕. Significant laboratory abnormality at screening.
✕. QTc interval greater than 470 ms or other clinically significant ECG abnormality at screening.
✕. Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, and vulvovaginal corticosteroids within 7 days prior to randomization.
✕. Have received any estrogen replacement therapy or vaginal topical products.