Status:
COMPLETED
Estrogen, Probiotics and Vaginal Health to Prevent HIV Infection in ACB Women
Lead Sponsor:
McMaster University
Collaborating Sponsors:
CIHR Canadian HIV Trials Network
Conditions:
HIV-1-infection
Bacterial Vaginoses
Eligibility:
FEMALE
18-49 years
Phase:
PHASE1
Brief Summary
This study will enrol African, Caribbean and Black (ACB) women who are known to have a more diverse vaginal microbiome, higher rates of bacterial vaginosis with lower numbers of protective lactobacill...
Detailed Description
Women are at increased risk of HIV acquisition compared with men. A number of biological factors are associated with increased risk, many of which likely enhance risk by increasing inflammation in the...
Eligibility Criteria
Inclusion
- African, Caribbean, Black
- Pre-menopausal women in good general health, as determined by the investigator
- Uterus and cervix present
- Negative pregnancy test
- Currently practicing barrier or non-hormonal forms of contraception, and planning to continue, for the duration of the study (barrier contraceptive, abstinence)
- Willing to undergo a pelvic exam by a female nurse/female doctor
- Willing to abstain from vaginal intercourse for 48 hours prior to sampling, over the entire course of the study
- Able to understand, comply and consent to protocol requirements and instructions
- Able to attend scheduled study visits and complete required investigations
Exclusion
- Currently lactating
- Pregnant: suspected, current or in the last 12 months
- Irregular menstrual cycle (less than 6 periods in a year) not related to contraceptive use, pregnancy or breastfeeding
- Post-menopausal
- Hormonal Contraceptive use or other hormonal treatment in the past 3 months
- Current Intra-Uterine Device (IUD) use
- Positive test result for Gonorrhea and/or Chlamydia
- Clinically obvious genital ulceration/lesions
- Symptomatic vaginal yeast infection or clinically significant vaginal discharge
- HIV-positive
- Any clinically significant abnormality on screening safety blood tests, that in the opinion of the investigator would preclude enrolment.
- Diagnosed blood clotting disorder
- Any genital tract procedure (e.g. biopsy) within the past 6 months
- Use of oral probiotic supplement, oral antibiotics or oral steroids within the past 30 days
- Current use of any vaginal products (except tampons) such as spermicides, microbicides, douching or drying products, antifungals, or steroids.
- Known intolerance of Lactobacillus-containing probiotic supplements
- Undiagnosed abnormal genital bleeding
- Known, suspected, or history of breast cancer
- Known or suspected estrogen-dependent malignant neoplasia (e.g. endometrial cancer)
- Currently taking immunosuppressive drugs
- Known or suspected hypersensitivity to any component of the Estring or RepHresh Pro-B products
- Diagnosis of endometrial hyperplasia
- Known liver dysfunction or disease; as long as liver function tests have failed to return to normal
- Active or past history of arterial thromboembolic disease (e.g. stroke, myocardial infarction, coronary heart disease)
- Partial or complete loss of vision due to ophthalmic vascular disease
- Porphyria
- Concomitant medication which in the opinion of the investigator may be associated with a significant drug interaction with the estrogen in Estring.
- The conditions below are grounds for exclusion based on the opinion of the investigator:
- Risk factors for estrogen dependent tumours, e.g. first degree heredity for breast cancer
- Diabetes mellitus with or without vascular involvement
- Migraine or (severe) headache
- Epilepsy
- A history of, or risk factors for, thromboembolic disorders
- Systemic lupus erythematosus
- Otosclerosis
- Cholelithiasis
- Leiomyoma (uterine fibroids)
- Endometriosis
- A history of endometrial hyperplasia
- Hypertension
- Asthma
- Diagnosed anemia
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03837015
Start Date
November 4 2019
End Date
December 14 2021
Last Update
December 17 2021
Active Locations (1)
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1
Women's Health in Women's Hands
Toronto, Ontario, Canada, M5B1J3