Vulvovaginal AtrophyPhase 1NCT05418426
A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 in Healthy PostMenopausal Women
A Phase 1 study testing IVR Dose 1, IVR Dose 2 and Oral Reference in people with Vulvovaginal Atrophy and Vasomotor Symptoms, run by Daré Bioscience, Inc. at 2 sites in Australia.
Trial 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. 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, IVR Dose 2 and Oral Reference
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesAustralia
- Study dates
- 18 Aug 2020to 27 Jan 2022
- Phase
- Phase 1
- 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 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
Who cannot join
- 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
Show all 28Show fewer
- 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 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; vaginal, vulvar, or cervical lesions, undiagnosed vaginal bleeding; or tenderness
- Subjects with a finding of clinically significant uterine fibroids at screening
- Subjects with a known hypersensitivity to progesterone, estradiol, Femring, or the components of the IVR (e.g., ethylene vinyl acetate)
- Subjects with known hypersensitivity to peanuts (Prometrium capsules contain peanut oil)
- Subjects with prior pelvic malignancies
- Subjects 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 subject 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 antigen positive subjects 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
- History of gallbladder disease unless gallbladder removed
- Symptomatic bacterial vaginosis
- Have fasting triglyceride of > 300 mg/dL and/or total cholesterol of > 300 mg/dL
- AST or ALT > 1.5 times the upper limit of normal
- Fasting glucose > 125 mg/dL
- 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 two 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.
- 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
Melbourne
Keogh Institute for medical Research
Nedlands
About this study
Official title: A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 (80μg Estradiol/4mg Progesterone and 160μg Estradiol/8mg Progesterone Intravaginal Rings) in Healthy PostMenopausal Women
An open-label study to assess the PK of estradiol, estrone and progesterone from the DARE-HRT1 intravaginal rings at two different dose strengths.
- Conditions
- Vulvovaginal Atrophy, Vasomotor Symptoms
- Being tested
- IVR Dose 1, IVR Dose 2, Oral Reference
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/progesterone 4 mg
IVR Dose 2Device
Estradiol 160ug/progesterone 8 mg
Oral ReferenceDrug
estradiol 1mg/progesterone 100 mg
| Study group | Role | What they receive |
|---|---|---|
| IVR: estradiol 80 ug/day + progesterone 4mg/day | Experimental | 28-day IVR 80/4 Receives: Device: IVR Dose 1 |
| IVR: estradiol 160 ug/day + progesterone 8mg /day | Experimental | 28-day IVR 160/8 Receives: Device: IVR Dose 2 |
| Oracle Estrace(R)/Prometrium(R) | Active comparator | 29 days (estradiol 1mg/progesterone 100 mg oral capsule) Receives: Drug: Oral Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine the Steady State Concentration (Css) for Estradiol
To describe the Pharmacokinetic parameters of estradiol in dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
Measured: 28 days
To Determine the Stead State Concentration (Css) for Estrone
To describe the Pharmacokinetic parameters of estrone in dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
Measured: 28 days
To Determine the Steady State Concentration (Css) for Progesterone
To describe the Pharmacokinetic parameters of progesterone in dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start18 Aug 2020
- Primary completion27 Apr 2021
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vulvovaginal AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daré Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Friend, PhD, Study director, Dare Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418426
- Sponsor's protocol ID
- DARE-HRT1-001
- Status last verified
- Aug 2023
- First submitted
- 10 Jun 2022
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 (80μg Estradiol/4mg Progesterone and 160μg Estradiol/8mg Progesterone Intravaginal Rings) in Healthy PostMenopausal Women
- ClinicalTrials.gov ID
- NCT05418426
- Acronym / sponsor ID
- DARE-HRT1-001
- Conditions
- Vulvovaginal Atrophy, Vasomotor Symptoms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Daré Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label study to assess the PK of estradiol, estrone and progesterone from the DARE-HRT1 intravaginal rings at two different dose strengths.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IVR: estradiol 80 ug/day + progesterone 4mg/day | Experimental | Device: IVR Dose 128-day IVR 80/4 |
| IVR: estradiol 160 ug/day + progesterone 8mg /day | Experimental | Device: IVR Dose 228-day IVR 160/8 |
| Oracle Estrace(R)/Prometrium(R) | Active comparator | Drug: Oral Reference29 days (estradiol 1mg/progesterone 100 mg oral capsule) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVR Dose 1Estradiol 80 ug/progesterone 4 mg | Device | IVR: estradiol 80 ug/day + progesterone 4mg/day |
| IVR Dose 2Estradiol 160ug/progesterone 8 mg | Device | IVR: estradiol 160 ug/day + progesterone 8mg /day |
| Oral Referenceestradiol 1mg/progesterone 100 mg | Drug | Oracle Estrace(R)/Prometrium(R) |
Primary outcome
To Determine the Steady State Concentration (Css) for Estradiol
Time frame: 28 days
To describe the Pharmacokinetic parameters of estradiol in dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
To Determine the Stead State Concentration (Css) for Estrone
Time frame: 28 days
To describe the Pharmacokinetic parameters of estrone in dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
To Determine the Steady State Concentration (Css) for Progesterone
Time frame: 28 days
To describe the Pharmacokinetic parameters of progesterone in dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Friend, PhD study director
Dare Bioscience
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IVR Dose 1, IVR Dose 2 and Oral Reference 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 5 inclusion and 28 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 15 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 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.
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 15 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?
To Determine the Steady State Concentration (Css) for Estradiol (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.