A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-H… (NCT05418426) | Clinical Trial Compass
CompletedPhase 1
A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 in Healthy PostMenopausal Women
Australia34 participantsStarted 2020-08-18
Plain-language summary
An open-label study to assess the PK of estradiol, estrone and progesterone from the DARE-HRT1 intravaginal rings at two different dose strengths.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Postmenopausal women with body mass index \>/= 18 and \</= 38 kg/m2
* Normal cervix and vagina
* An intact uterus
* An acceptable results from an endometrial biopsy
* normal mammogram report within 24 months of screening
Exclusion Criteria:
Prior abnormal cervical screening test (CST) or Pap result within 2 years of screening. Subject can have atypical squamous cells of undetermined significance (ASCUS), if HPV negative.
Subjects with any self-reported active sexually transmitted disease and/or evidence of infection based on visual vaginal exam by the investigator
Subjects with a UTI during screening as assessed by urine dipstick test with abnormal test findings (any positive result for leukocytes AND any positive result for nitrites)
Subjects with \> 4 mm endometrium lining at screening (on the transvaginal ultrasound)
Have a history of endometrial hyperplasia or cervical or uterine carcinoma
Subjects with indwelling catheters or requiring intermittent catheterization
Subjects with multiple or unsuccessful (e.g., still having symptoms) pelvic reconstructive surgery, or suffers from pelvic relaxation
Subjects who have had a hysterectomy
Subjects taking any estrogen and/or progesterone products (see Section 4.1 for washout requirements)
Subjects with concomitant use of personal lubricants (water-based lubricants are allowed) or any intravaginal product or medication, either by prescription or over-the-counter (e.g., Femring \[estradiol acetate…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To Determine the Steady State Concentration (Css) for Estradiol
Timeframe: 28 days
2
To Determine the Stead State Concentration (Css) for Estrone
Timeframe: 28 days
3
To Determine the Steady State Concentration (Css) for Progesterone