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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05418426
Registration number
NCT05418426
Ethics application status
Date submitted
10/06/2022
Date registered
14/06/2022
Date last updated
8/12/2022
Titles & IDs
Public title
A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 in Healthy PostMenopausal Women
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Scientific 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
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Secondary ID [1]
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DARE-HRT1-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Vulvovaginal Atrophy
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Vasomotor Symptoms
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Condition category
Condition code
Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - IVR Dose 1
Treatment: Devices - IVR Dose 2
Treatment: Drugs - Oral Reference
Experimental: IVR: estradiol 80 ug/day + progesterone 4mg/day - 28-day IVR 80/4
Experimental: IVR: estradiol 160 ug/day + progesterone 8mg /day - 28-day IVR 160/8
Active Comparator: Oracle Estrace(R)/Prometrium(R) - 29 days (estradiol 1mg/progesterone 100 mg oral capsule)
Treatment: Devices: IVR Dose 1
Estradiol 80 ug/progesterone 4 mg
Treatment: Devices: IVR Dose 2
Estradiol 160ug/progesterone 8 mg
Treatment: Drugs: Oral Reference
estradiol 1mg/progesterone 100 mg
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To determine the steady state concentration (Css) for estradiol
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Assessment method [1]
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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)
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Timepoint [1]
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28 days
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Primary outcome [2]
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To determine the stead state concentration (Css) for estrone
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Assessment method [2]
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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)
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Timepoint [2]
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28 days
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Primary outcome [3]
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To determine the steady state concentration (Css) for progesterone
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Assessment method [3]
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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)
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Timepoint [3]
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28 days
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key 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 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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/08/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/01/2022
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Sample size
Target
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Accrual to date
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Final
31
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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PARC Clinical Research - Melbourne
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Recruitment hospital [2]
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Keogh Institute for medical Research - Nedlands
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment postcode(s) [2]
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- Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Daré Bioscience, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05418426
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David Friend, PhD
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Address
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Dare Bioscience
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05418426
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