Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-24 @ 11:58 AM
NCT ID:
NCT02744261
Eligibility Criteria:
All participants must meet all of the inclusion criteria to participate in this study.
Inclusion Criteria:
All participants must meet all of the inclusion criteria to participate in this study.
* Eligible male participants must be 18 years of age or older
* Eligible female participants must be 18-45 years of age
Inclusion criteria include men and women who:
* Report receptive anal intercourse (RAI) at least twice in the past 6 months
* Are willing to use each study product in conjunction with RAI on at least one occasion in each data collection period (resulting in a minimum of 3 RAI events during each product evaluation period; on average every 2 weeks, all 3 products across an average of 6 -12 weeks)
* Are willing and able to respond to study data collection systems via phone and internet, attend all study visits, and participate in in-depth qualitative interviews
Additional Inclusion Criteria for Female Volunteers:
* Report vaginal-penile intercourse (VI) at least twice in the past 6 months
* Willing to use each study suppository formulation in conjunction with VI on at least one occasion in each data collection period (resulting in a minimum of 2 vaginal intercourse events during the course of the study)
* Report consistent use of an effective birth control method: e.g., hormonal contraceptive, IUD, bilateral tubal ligation, Essure® or any non-incisional permanent birth control procedure, hysterectomy (partial or total, with/without oophorectomy), partner's vasectomy/salpingectomy
Exclusion Criteria:
* Have a sensitivity or allergy to vaginal, anal, or rectal products
* Have a sensitivity or allergy to any of the ingredients contained in the study products
* Have a sensitivity or allergy to sesame seeds
* Are HIV-positive at baseline, or have a known HIV-positive sexual partner
* Have an active rectal or reproductive tract infection requiring treatment per current CDC guidelines or have other condition that, in the opinion of the investigator/study clinician, make the patient unsuitable for the study or unable to comply with study requirements (Note: HSV seropositivity without active genital lesions is not an exclusion criteria)
* Urinary tract infection (UTI)
* Have current inflammatory bowel disease (IBD) or history of active IBD within last 3 months
* Have any other significant colorectal symptom(s) as determined by medical history, participant self-report, or physical exam (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, presence of symptomatic external hemorrhoids, and presence of any painful anorectal conditions that would be tender to manipulation)
* Have any other clinical condition or prior therapy that, in the opinion of the investigator/study clinician, would make the patient unsuitable for the study or unable to comply with the study requirements (including, as determined by medical history, participant self-report, or physical exam: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate gland enlargement; taking psychotropic medications such as monoamine inhibitors, tricyclic antidepressants, SSRIs)
* Are unwilling to refrain from use of nonoxynol-9 (N9) for the duration of the study
* Are currently enrolled in other rectal or vaginal product studies
* Are unable or unwilling to communicate in English, or
* Are unable or unwilling to give written informed consent
Additional Exclusion Criteria for Female Volunteers:
* Are pregnant or breastfeeding. Pregnancy testing will be conducted at Visits 1-4 (screening and prior to any product use period)
* Have completed menopause (i.e., at least 12 months without menstrual periods)
* Are currently attempting to get pregnant or have an intention to get pregnant during their participation in the study
* Are unwilling to refrain from use of any vaginal product (inclusive of douching; exclusive of tampons during menses) other than study products
* Have clinically significant abnormal pelvic findings and/or findings requiring therapy as a function of clinical exam at Visit 1
* Report being within 30 days of their last pregnancy outcome or gynecologic surgical procedure
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02744261
Study Brief:
Protocol Section:
NCT02744261