A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 in Healthy PostMenopausal Women

NCT05418426 | Completed Phase 1 Results

• 1 other identifier: DARE-HRT1-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Vulvovaginal Atrophy; Vasomotor Symptoms

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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)

  28 days

Study Arms (3)

IVR: estradiol 80 ug/day + progesterone 4mg/day

EXPERIMENTAL

28-day IVR 80/4

Device: IVR Dose 1

IVR: estradiol 160 ug/day + progesterone 8mg /day

EXPERIMENTAL

28-day IVR 160/8

Device: IVR Dose 2

Oracle Estrace(R)/Prometrium(R)

ACTIVE COMPARATOR

29 days (estradiol 1mg/progesterone 100 mg oral capsule)

Drug: Oral Reference

Interventions

IVR Dose 1 DEVICE

Estradiol 80 ug/progesterone 4 mg

IVR: estradiol 80 ug/day + progesterone 4mg/day

IVR Dose 2 DEVICE

Estradiol 160ug/progesterone 8 mg

IVR: estradiol 160 ug/day + progesterone 8mg /day

Oral Reference DRUG

estradiol 1mg/progesterone 100 mg

Oracle Estrace(R)/Prometrium(R)

Eligibility Criteria

• Gender Eligibility Details: Must be female.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daré Bioscience, Inc.: lead

Study Sites (2)

PARC Clinical Research

Melbourne, Australia

Location

Keogh Institute for medical Research

Nedlands, Australia

Location

Limitations and Caveats

One participant randomized into the Oral Reference group was never dosed as the participant was terminated due to a protocol violation.

Results Point of Contact

• Title: Jessica Hatheway, VP of Clinical Operations
• Organization: Daré Bioscience, Inc.

jhatheway@darebioscience.com

858-926-7655

Study Officials

• David Friend, PhD

  Dare Bioscience

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 14, 2022
• Study Start: August 18, 2020
• Primary Completion: April 27, 2021
• Study Completion: January 27, 2022
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2023-08

Locations

AU (2)