| Eligibility |
Inclusion Criteria:
1. Subjects must be females >= 18 years of age with no known medical conditions that, in
the Investigator's opinion, may interfere with study participation.
2. Subjects may engage in heterosexual intercourse between Screening and Day-1, but must
agree to abstain from sexual intercourse and/or sexual activity throughout the 7 days
following treatment.
3. Subjects of childbearing potential should use adequate birth control between Screening
and Day 1 if engaging in heterosexual intercourse, and should not plan on becoming
pregnant for the duration of the study. Acceptable forms of birth control include oral
contraceptives ("the pill"), intrauterine devices (IUDs), contraceptive implants under
the skin, patches or injections, and non-polyurethane condoms (e.g., latex,
polyisoprene) without spermicide. Subjects in same sex relationships, or monogamous
relationships with vasectomized males, may also participate. Abstinence may also be
acceptable, per the Investigator's judgment. Oral or transdermal hormonal
contraceptives must be in use for 1 full cycle (e.g., 4 to 8 weeks) prior to study
drug application. Injectable or implanted contraceptives (e.g., Depo-Provera,
Nexplanon, or hormonal IUD) must have been injected/inserted at least 7 days prior to
study drug application.
4. Subjects who are not of childbearing potential will not need a urine pregnancy test
prior to dosing or at subsequent visits. Subjects are considered to be of non-child
bearing potential if one of the following is satisfied:
1. Postmenopausal for at least 1 year prior to the Screening Visit (Visit 1)
(defined as amenorrheic for more than 1 continuous year), or
2. Surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy,
or hysterectomy) at least 6 months before first dose, or
3. Non-surgical permanent sterilization procedure performed at least 3 months prior
to study drug application.
5. Subjects must be willing to refrain from the use of all intra-vaginal products (e.g.,
douches, feminine deodorant sprays, female condoms, spermicides, vaginal moisturizers
or lubricants, tampons, vaginal birth control rings [e.g., NuvaRing®], and diaphragms)
through the study or Study Exit/Early Discontinuation.
Exclusion Criteria:
1. Subjects with active BV, vulvovaginitis, or other active infectious causes of
cervicitis, vaginitis, or vulvitis, based on the results of the thorough clinical
assessments and testing as described above or genital lesions or ulcers consistent
with HPV, Herpes simplex, syphilis, chancroid, etc.). Subjects with a history of
genital herpes or condylomata who have been asymptomatic for at least 6 months may be
considered for eligibility.
2. Potential subjects who are pregnant or are breastfeeding or, if of child-bearing
potential, unwilling to practice acceptable means of birth control or abstinence
during the study as described above.
3. Subjects with a vaginal, vulvar, or genitourinary condition that, according to the
Investigator's judgment, may confound the interpretation of clinical assessments. This
includes urinary tract infections requiring antibiotics.
4. Subjects with a history of regional enteritis, ulcerative colitis, or a history of
Clostridium difficile-associated diarrhea.
5. Subjects with known current drug or alcohol abuse that could impact study compliance.
6. Subjects currently receiving or who have received antifungal or antibacterial therapy
(systemic or intravaginal) within 14 days of the Screening Visit (Visit 1).
7. Subjects who have used any other investigational product within 30 days of the
Screening Visit (Visit 1).
8. Subjects with HPV 16 or 18 at screening (performed on subjects >25 years old).
9. Subjects with known sensitivity to clindamycin phosphate or other lincosamides or any
of the inactive ingredients in the study drug.
10. Subjects with a history of any severe acute or chronic medical or psychiatric
condition or laboratory abnormality that could increase the risk associated with study
participation or study treatment administration or could interfere with the
interpretation of study results and, in the judgment of the Investigator, would make
the subject inappropriate for entry into the study.
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