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

NCT ID: NCT02092571

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-08-31

Brief Summary

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

Conditions

Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment A

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

Group Type: EXPERIMENTAL

Progesterone vaginal ring,

Intervention Type: DRUG

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

Treatment B

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

Group Type: EXPERIMENTAL

Progesterone vaginal ring,

Intervention Type: DRUG

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

Interventions

Progesterone vaginal ring,

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

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

1. Naturally postmenopausal woman with an intact uterus, 40 to 70 years of age, inclusive.

2. The subject has serum estradiol and FSH levels that are consistent with the subject being postmenopausal.

3. The subject has no clinically significant abnormality findings observed during pelvic, breast, and vaginal examination or based on mammogram and Pap smear evaluations.

4. 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.

Exclusion:

1. The subject has a history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, urologic, gynecologic, immunologic, dermatologic, neurologic, or psychiatric disease.

2. The subject has a history of toxic shock syndrome.

3. The subject has a history of jaundice associated with previous use of oral contraceptives.

4. 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)

5. 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.

6. 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.

7. The subject has a positive pregnancy test at screening or at any time during the study.

8. 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).

9. 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
• transdermal estrogen alone or estrogen/progestin products within 28 days
• oral estrogen or progestin therapy within 56 days
• intrauterine progestin therapy within 56 days
• progestin implants or estrogen alone injectable drug therapy within 3 months
• estrogen pellet therapy or progestin injectable therapy within 6 months

10. The subject has a vaginal ultrasonography at screening that confirms an active endometrial lining and/or an endometrial thickness of ≥4 mm.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 12355

Miami, Florida, United States

Countries

United States

Other Identifiers

DR201-BE-10021

Identifier Type: -

Identifier Source: org_study_id