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

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 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.

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

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

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 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.

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)