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Vulvovaginal AtrophyPhase 1/2DARE-HRT1NCT05367973

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

A Phase 1/2 study testing IVR Dose 1 and IVR Dose 2 in people with Vulvovaginal Atrophy and Vasomotor Symptoms, run by Daré Bioscience, Inc. at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Vulvovaginal Atrophy, Vasomotor Symptoms
What is being tested?
IVR Dose 1 and IVR Dose 2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
2 sitesAustralia
Study dates
11 Apr 2022to 23 Mar 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Postmenopausal women with a body mass index (BMI) ≥ 18 and ≤ 38 kg/m2. BMI = weight (kg)/(height [m])2
  • Postmenopausal is defined as 12-months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy (although participants who have had a hysterectomy are not eligible for this study).
  • The investigator will need to determine if a participant's BMI falling within the obese-severely obese range could potentially interfere with the protocol-required procedures, specifically the pelvic examinations described in Inclusion Criterion #2. Any participant whose BMI is determined to fall into this category should be excluded from trial participation.
  • Normal cervix, vagina, uterus, and adnexa based on speculum examination and bimanual examination.
  • Normal transvaginal ultrasound, and endometrial biopsy results as follows:
  • If endometrial thickness is ≤ 4.0 mm in a participant without postmenopausal vaginal bleeding, an endometrial biopsy is not indicated for the purposes of screening,
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  • If endometrial thickness is > 4.0 mm ≤ 6.0 mm in a participant without postmenopausal vaginal bleeding, an acceptable result from an evaluable screening endometrial biopsy, evaluated by a pathologist, is required for inclusion into the study. Tissue must be read as benign, inactive, or atrophic endometrium by at least 1 pathologist,
  • 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.

Who cannot join

  • 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.
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  • 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.
  • Participants with concomitant use of personal lubricants (water-based lubricants are allowed) or any intravaginal product or medication, either by prescription or over-the-counter (OTC) (e.g., Femring [estradiol acetate vaginal ring], ESTRING® [estradiol vaginal ring]) with the exception of those who agree not to use these products during the IVR use period.
  • Self-reported or observed vaginal irritation unrelated to VVA; vaginal, vulvar, or cervical lesions, undiagnosed vaginal bleeding; or tenderness.
  • Participants with a finding of clinically significant uterine fibroids at screening.
  • Participants with a known hypersensitivity to progesterone, estradiol, Femring, or the components of the IVR (e.g., ethylene vinyl acetate).
  • Participants with prior pelvic malignancies.
  • Participants with a history of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or study treatment administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the participant inappropriate for entry into the trial. This includes but is not limited to the following:
  • Human immunodeficiency virus (HIV) infection (confirmed by medical history/ serology testing),
  • Active chronic hepatitis B or hepatitis C infection including hepatitis B surface antigen and hepatitis C antibody positive participants with or without abnormal liver enzymes (confirmed by medical history/serology testing),
  • Concurrent neurodegenerative disease,
  • Cardiovascular: uncontrolled hypertension, unstable angina, myocardial infarction or symptomatic congestive heart failure within the past 6 months, serious uncontrolled cardiac arrhythmia, use of Class 1 antiarrhythmic medications, or history of venous thromboembolism or stroke,
  • Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol,
  • Participants with known thrombophilias may not participate in this study because estrogen-based products are contraindicated for them,
  • Symptomatic bacterial vaginosis.
  • Fasting triglyceride of > 3.39 mmol/L and/or total cholesterol of > 7.77 mmol/L.
  • Aspartate aminotransferase or alanine aminotransferase > 1.5 times the upper limit of normal.
  • Fasting glucose > 6.94 mmol/L.
  • Evidence of current alcohol or drug abuse in the past 60 days including a positive result from the urine drugs of abuse or alcohol screen, or history of drug or alcohol dependence in the last 2 years, as assessed by principal investigator. Alcohol abuse is defined as greater than 14 standard units/week for females and drug abuse is defined as known psychiatric or substance abuse disorder that would interfere with participation with the requirements of this study, including current use of any illicit drugs. Use of medical cannabis is not exclusionary.
  • Participation in any other investigational drug or device trial in which administration of an investigational study drug/device occurred within 30 days or placement of a non-drug eluting medical device within 15 days prior to screening.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • PARC Clinical Research

    Adelaide, Southern Australia, 5000

  • Keogh Institute for Medical Research

    Nedlands, Western Australia, 6009

Other trials in Australia

About this study

Official title: A Phase 1/2,, Open-label, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of DARE-HRT1 (80ug Estradiol/4 mg Progesterone and 160ug Estradiol/8 mg Progesterone Intravaginal Rings) Over 12 Weeks in Healthy Postmenopausal Women

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.

Being tested
IVR Dose 1, IVR Dose 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVR Dose 1Device

    Estradiol 80 ug/day + progesterone 4 mg/day

  • IVR Dose 2Device

    Estradiol 160 ug/day + progesterone 8 mg/day

Study groups in NCT05367973
Study groupRoleWhat they receive
IVR: Estradiol 80 ug/day + progesterone 4mg/dayExperimental12-week IVR 80/4
Receives: Device: IVR Dose 1
IVR Estradiol 160 ug/day + progesterone 8 mg/dayExperimental12-week IVR 160/8
Receives: Device: IVR Dose 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Emergent Adverse Events

    To assess the safety and tolerability of DARE-HRT1 Intravaginal rings

    Measured: 12 weeks

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

    To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)

    Measured: 12 weeks (3- 28 day cycles)

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

    To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)

    Measured: 12 weeks (3- 28 day cycles)

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

    To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)

    Measured: 12 weeks (3- 28day cycles)

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

    To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)

    Measured: 12 weeks (3- 28 day cycles)

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

    To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)

    Measured: 12 weeks (3- 28 day cycles)

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

    To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)

    Measured: 12 weeks (3- 28day cycles)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2022
  2. Study start11 Apr 2022
  3. Primary completion9 Jan 2023
  4. Study completion23 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05367973
Sponsor's protocol ID
DARE-HRT1-002
Acronym
DARE-HRT1
Status last verified
Oct 2024
First submitted
2 May 2022
Last updated
31 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Thurman A, Hull ML, Stuckey B, Hatheway J, Zack N, Mauck C, Friend D. A phase 1/2, open-label, parallel group study to evaluate the preliminary efficacy and usability DARE-HRT1 (80 mug estradiol/4 mg progesterone and 160 mug estradiol/8 mg progesterone intravaginal RinGSM) over 12 weeks in healthy postmenopausal women. Menopause. 2023 Sep 1;30(9):940-946. doi: 10.1097/GME.0000000000002230. Epub 2023 Aug 7.

    PubMed 37625088

  • Thurman A, Hull ML, Stuckey B, Hatheway J, Zack N, Mauck C, Friend D. A phase 1/2, open-label, parallel group study to evaluate the safety and pharmacokinetics of DARE-HRT1 (80 mug estradiol/4 mg progesterone and 160 mug estradiol/8 mg progesterone intravaginal rings) over 12 weeks in healthy postmenopausal women. Menopause. 2023 Aug 1;30(8):817-823. doi: 10.1097/GME.0000000000002210. Epub 2023 Jun 20.

    PubMed 37339390

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IVR Dose 1 and IVR Dose 2 in people with Vulvovaginal Atrophy and Vasomotor Symptoms, run by Daré Bioscience, Inc. at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05367973, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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