A Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings in Postmenopausal Women

NCT02092571 | Completed Phase 1

• 1 other identifier: DR201-BE-10021
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

A study to assess the pharmacokinetics of 2 progesterone vaginal rings in postmenopausal women

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• baseline-adjusted AUCt

  16 weeks

• baseline-adjusted AUC∞

  16 weeks

• baseline-adjusted Cmax

  16 weeks

Secondary Outcomes (9)

• baseline-adjusted tmax

  16 weeks

• baseline-unadjusted AUCt

  16 weeks

• baseline-adjusted λz

  16 weeks

• baseline-adjusted t½

  16 weeks

• baseline-unadjusted AUC∞

  16 weeks

Study Arms (2)

Treatment A

EXPERIMENTAL

1 ring intravaginal for 7 days, produced from the new process

Drug: Progesterone vaginal ring,

Treatment B

EXPERIMENTAL

1 ring intravaginal for 7 days, produced from the legacy process

Drug: Progesterone vaginal ring,

Interventions

Progesterone vaginal ring, DRUG

Participants will be randomized to receive treatments in 1 of 2 treatment sequences (AB or BA)

Also known as: Treatment A - DR-201, progesterone vaginal ring, 20% (w/w),, 11 mg/day, produced from the NEW process and, Treatment B - DR-201, progesterone vaginal ring, 20% (w/w),, 11 mg/day, produced from the LEGACY process

Treatment A; Treatment B

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Naturally postmenopausal woman with an intact uterus, 40 to 70 years of age, inclusive.
• The subject has serum estradiol and FSH levels that are consistent with the subject being postmenopausal.
• The subject has no clinically significant abnormality findings observed during pelvic, breast, and vaginal examination or based on mammogram and Pap smear evaluations.
• The subject will agree to be treated with 1 mg/day estradiol oral tablets for at least 28 days before insertion of the first vaginal ring and throughout the study.

You may not qualify if:

• The subject has a history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, urologic, gynecologic, immunologic, dermatologic, neurologic, or psychiatric disease.
• The subject has a history of toxic shock syndrome.
• The subject has a history of jaundice associated with previous use of oral contraceptives.
• The subject has contraindications to the use of estrogen or progesterone that include, but are not limited to, the following:
• known sensitivity to estrogen or progesterone or related drugs
• known hypersensitivity to study medication ingredients, including FD\&C Yellow No. 5 (tartrazine) present in estradiol tablets
• undiagnosed vaginal bleeding or high risk for endometrial cancer
• breast mass on examination
• known, suspected, or family history of estrogen- or progesterone-dependent neoplasia (now or in the past)
• The subject has low-grade squamous intraepithelial lesion (LSIL) or worse as observed in the Pap smear at screening. Any other abnormal finding on the Pap smear that the investigator considers clinically significant (such as atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion \[HSIL; ASC-H\], atypical glandular cells \[AGC\]); or any Pap result that would necessitate further evaluation by biopsy and/or colposcopy.
• The subject has any abnormal finding or condition deemed clinically significant by the investigator at screening that is a contraindication to the use of progestins, estrogen, or a vaginal ring.
• The subject has a positive pregnancy test at screening or at any time during the study.
• Current treatment with progesterone, other progestins, or estrogen (other than estradiol 1-mg tablets, progesterone 200-mg capsules, or medroxyprogesterone acetate 10-mg tablets required for this study purpose).
• Use of any of the following medications within the time frames noted below before the start of estrogen treatment:
• vaginal hormonal products (rings, creams, or gels) within 7 days

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (1)

Teva Investigational Site 12355

Miami, Florida, United States

Location

Study Officials

• Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 20, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

US (1)