CompletedPhase 1/2

Study of DARE-HRT1 Over 12 Weeks in Healthy PostMenopausal Women

Australia21 participantsStarted 2022-04-11

Plain-language summary

Randomized, Open-label 2-arm, parallel group study in approximately 20 healthy postmenopausal women to assess the safety of DARE-HRT1 Intravaginal Rings in two different dose strengths and the PK of progesterone and estradiol from the Intravaginal Rings.

Who can participate

SexFEMALE

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 a body mass index (BMI) ≥ 18 and ≤ 38 kg/m2. BMI = weight (kg)/(height \[m\])2
✓. Normal cervix, vagina, uterus, and adnexa based on speculum examination and bimanual examination.
✓. Normal transvaginal ultrasound, and endometrial biopsy results as follows:
✓. Current on all Australian screening requirements for cervical cancer.
✓. Able and willing to correctly and independently complete all study procedures.
✓. Able and willing to stop any ongoing HRT in accordance with the appropriate washout periods (see Section 4.1 for washout requirements). Participants who are using HRT that requires more than 8 weeks to wash out (e.g., progestogen implants or progestogen injectable drug therapy, estrogen alone injectable drug therapy or estrogen pellet therapy) will not be eligible.
✓. Able to read, understand, and provide written informed consent after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures.
✓. Normal mammogram report within 24 months of screening.

Exclusion criteria

✕. Prior abnormal cervical screening test or Papanicolaou result within 2 years of screening. Participant can have atypical squamous cells of undetermined significance, if human papillomavirus negative.
✕. Participants with any self-reported active sexually transmitted disease and/or evidence of infection based on vaginal visual examination by the investigator.
✕. Participants with a urinary tract infection during screening as assessed by urine dipstick test with abnormal test findings (any positive result for leukocytes AND any positive result for nitrites).
✕. Have a history of endometrial hyperplasia or cervical or uterine carcinoma.
✕. Participants with indwelling catheters or requiring intermittent catheterization.
✕. Participants with multiple or unsuccessful (e.g., still having symptoms) pelvic reconstructive surgery, or who suffer from pelvic relaxation.
✕. Participants who have had a hysterectomy.
✕. Participants taking any estrogen and/or progesterone products who are not willing to stop this treatment during their participation in this trial (see Section 4.1 for washout requirements). Participants who are using HRT that requires more than 8 weeks to wash out (e.g., progestogen implants or progestogen injectable drug therapy, estrogen alone injectable drug therapy or estrogen pellet therapy) will not be eligible.

What they're measuring

Number of Participants With Treatment Emergent Adverse Events

Timeframe: 12 weeks

Determination of Maximum Plasma Concentration of Progesterone (Cmax) Per Cycle

Timeframe: 12 weeks (3- 28 day cycles)

Determination of Time That Maximum Progesterone Plasma Concentration Was Observed (Tmax)

Timeframe: 12 weeks (3- 28 day cycles)

Determination of Progesterone Steady-state Concentration (Css) Per Cycle

Timeframe: 12 weeks (3- 28day cycles)

Determination of Time That Maximum Estradiol Plasma Concentration Was Observed (Tmax)

Timeframe: 12 weeks (3- 28 day cycles)

Determination of Maximum Plasma Concentration of Estradiol (Cmax) Per Cycle

Timeframe: 12 weeks (3- 28 day cycles)

Determination of Estradiol Steady-state Concentration (Css) Per Cycle

Timeframe: 12 weeks (3- 28day cycles)

Trial details

NCT IDNCT05367973

SponsorDaré Bioscience, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-09

Results submitted2023-08-22

View on ClinicalTrials.gov More Vulvovaginal Atrophy trials

Who can participate

SexFEMALE

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 a body mass index (BMI) ≥ 18 and ≤ 38 kg/m2. BMI = weight (kg)/(height \[m\])2
✓. Normal cervix, vagina, uterus, and adnexa based on speculum examination and bimanual examination.
✓. Normal transvaginal ultrasound, and endometrial biopsy results as follows:
✓. Current on all Australian screening requirements for cervical cancer.
✓. Able and willing to correctly and independently complete all study procedures.
✓. Able and willing to stop any ongoing HRT in accordance with the appropriate washout periods (see Section 4.1 for washout requirements). Participants who are using HRT that requires more than 8 weeks to wash out (e.g., progestogen implants or progestogen injectable drug therapy, estrogen alone injectable drug therapy or estrogen pellet therapy) will not be eligible.
✓. Able to read, understand, and provide written informed consent after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures.
✓. Normal mammogram report within 24 months of screening.

Exclusion criteria

✕. Prior abnormal cervical screening test or Papanicolaou result within 2 years of screening. Participant can have atypical squamous cells of undetermined significance, if human papillomavirus negative.
✕. Participants with any self-reported active sexually transmitted disease and/or evidence of infection based on vaginal visual examination by the investigator.
✕. Participants with a urinary tract infection during screening as assessed by urine dipstick test with abnormal test findings (any positive result for leukocytes AND any positive result for nitrites).
✕. Have a history of endometrial hyperplasia or cervical or uterine carcinoma.
✕. Participants with indwelling catheters or requiring intermittent catheterization.
✕. Participants with multiple or unsuccessful (e.g., still having symptoms) pelvic reconstructive surgery, or who suffer from pelvic relaxation.
✕. Participants who have had a hysterectomy.
✕. Participants taking any estrogen and/or progesterone products who are not willing to stop this treatment during their participation in this trial (see Section 4.1 for washout requirements). Participants who are using HRT that requires more than 8 weeks to wash out (e.g., progestogen implants or progestogen injectable drug therapy, estrogen alone injectable drug therapy or estrogen pellet therapy) will not be eligible.

What they're measuring

Number of Participants With Treatment Emergent Adverse Events

Timeframe: 12 weeks

Determination of Maximum Plasma Concentration of Progesterone (Cmax) Per Cycle

Timeframe: 12 weeks (3- 28 day cycles)

Determination of Time That Maximum Progesterone Plasma Concentration Was Observed (Tmax)

Timeframe: 12 weeks (3- 28 day cycles)

Determination of Progesterone Steady-state Concentration (Css) Per Cycle

Timeframe: 12 weeks (3- 28day cycles)

Determination of Time That Maximum Estradiol Plasma Concentration Was Observed (Tmax)

Timeframe: 12 weeks (3- 28 day cycles)

Determination of Maximum Plasma Concentration of Estradiol (Cmax) Per Cycle

Timeframe: 12 weeks (3- 28 day cycles)

Determination of Estradiol Steady-state Concentration (Css) Per Cycle

Timeframe: 12 weeks (3- 28day cycles)