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
SexFEMALE
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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…
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