CompletedPhase 4

Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV

United States40 participantsStarted 2018-11-28

Plain-language summary

A multi-center, open-label study to evaluate the treatment of one oral dose of 2g Solosec™ (Secnidazole) in adolescent girls with BV

Age range12 Years – 17 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.

✓. Are adolescent girls 12-17 years of age.
✓. Are willing and able to give written informed assent with a written informed consent from a parent or legal guardian. (Amendment 01- Assent only if State allowed)
✓. Are in good general health including as confirmed by a medical history and physical examination, with no known medical or mental health conditions that, in the Investigator's opinion, may interfere with study participation.
✓. Willing and able to participate in the study as an outpatient, make required visits to the study center, and comply with all study requirements.
✓. Have a negative urine pregnancy test result prior to study treatment initiation. In addition, female patients of childbearing potential must be using an acceptable form of birth control as determined by the Investigator (e.g., oral contraception, implantable, injectable or transdermal hormonal contraception, intrauterine device \[IUD\], double-barrier methods, have a vasectomized partner or abstinence \[if the patient becomes sexually active they must use one of the acceptable methods of birth control\]). Note: NuvaRing® or any other vaginal ring products are not permitted.
✓. Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:
✓. Off-white (milky or gray), thin, homogeneous vaginal discharge AND
✓. Vaginal pH \> 4.5 AND

✕. Are pregnant, lactating, or planning to become pregnant during the study.
✕. Are menstruating or have vaginal bleeding at the Baseline Visit (Day 1).
✕. Are menopausal as determined by the Investigator.
✕. Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex or human papilloma virus.
✕. Have active genital lesions, including active Herpes simplex lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the Investigator (patients with genital warts that are not being treated may be enrolled).
✕. Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline Visit (Day 1).
✕. Are using NuvaRing® or any other vaginal ring products.
✕. Have consumed any alcohol within 12 hours prior to treatment with study medication.

Clinical Outcome Responder

Timeframe: At TOC visit study day 7-14

Nugent Score

Timeframe: At TOC visit study day 7-14

Investigator Clinical Assessment

Timeframe: At TOC visit study day 7-14

Patient's Continued Clinical Response

Timeframe: At TOC visit study day 7-14

NCT IDNCT03937869

SponsorLupin Research Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-05

Who can participate

Age range12 Years – 17 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.

✓. Are adolescent girls 12-17 years of age.
✓. Are willing and able to give written informed assent with a written informed consent from a parent or legal guardian. (Amendment 01- Assent only if State allowed)
✓. Are in good general health including as confirmed by a medical history and physical examination, with no known medical or mental health conditions that, in the Investigator's opinion, may interfere with study participation.
✓. Willing and able to participate in the study as an outpatient, make required visits to the study center, and comply with all study requirements.
✓. Have a negative urine pregnancy test result prior to study treatment initiation. In addition, female patients of childbearing potential must be using an acceptable form of birth control as determined by the Investigator (e.g., oral contraception, implantable, injectable or transdermal hormonal contraception, intrauterine device \[IUD\], double-barrier methods, have a vasectomized partner or abstinence \[if the patient becomes sexually active they must use one of the acceptable methods of birth control\]). Note: NuvaRing® or any other vaginal ring products are not permitted.
✓. Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:
✓. Off-white (milky or gray), thin, homogeneous vaginal discharge AND
✓. Vaginal pH \> 4.5 AND

✕. Are pregnant, lactating, or planning to become pregnant during the study.
✕. Are menstruating or have vaginal bleeding at the Baseline Visit (Day 1).
✕. Are menopausal as determined by the Investigator.
✕. Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex or human papilloma virus.
✕. Have active genital lesions, including active Herpes simplex lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the Investigator (patients with genital warts that are not being treated may be enrolled).
✕. Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline Visit (Day 1).
✕. Are using NuvaRing® or any other vaginal ring products.
✕. Have consumed any alcohol within 12 hours prior to treatment with study medication.