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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
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
Secondary ID [1] 0 0
DARE-HRT1-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vulvovaginal Atrophy 0 0
Vasomotor Symptoms 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the steady state concentration (Css) for estradiol
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
To determine the stead state concentration (Css) for estrone
Timepoint [2] 0 0
28 days
Primary outcome [3] 0 0
To determine the steady state concentration (Css) for progesterone
Timepoint [3] 0 0
28 days

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
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/01/2022
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
PARC Clinical Research - Melbourne
Recruitment hospital [2] 0 0
Keogh Institute for medical Research - Nedlands
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Daré Bioscience, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05418426
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Friend, PhD
Address 0 0
Dare Bioscience
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries