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

Overview

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

Full Title of Study: “An Open-Label, Single-Dose, Randomized, 2-Treatment, 2-Period Crossover Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings 20% (w/w) in Postmenopausal Women”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2014

Interventions

  • Drug: Progesterone vaginal ring,
    • Participants will be randomized to receive treatments in 1 of 2 treatment sequences (AB or BA)

Arms, Groups and Cohorts

  • Experimental: Treatment A
    • 1 ring intravaginal for 7 days, produced from the new process
  • Experimental: Treatment B
    • 1 ring intravaginal for 7 days, produced from the legacy process

Clinical Trial Outcome Measures

Primary Measures

  • baseline-adjusted AUCt
    • Time Frame: 16 weeks
  • baseline-adjusted AUC∞
    • Time Frame: 16 weeks
  • baseline-adjusted Cmax
    • Time Frame: 16 weeks

Secondary Measures

  • baseline-adjusted tmax
    • Time Frame: 16 weeks
  • baseline-unadjusted AUCt
    • Time Frame: 16 weeks
  • baseline-adjusted λz
    • Time Frame: 16 weeks
  • baseline-adjusted t½
    • Time Frame: 16 weeks
  • baseline-unadjusted AUC∞
    • Time Frame: 16 weeks
  • baseline-unadjusted Cmax
    • Time Frame: 16 weeks
  • baseline-unadjusted tmax
    • Time Frame: 16 weeks
  • baseline-unadjusted λz
    • Time Frame: 16 weeks
  • baseline-unadjusted t½
    • Time Frame: 16 weeks

Participating in This Clinical Trial

Inclusion: 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.

Gender Eligibility: Female

Minimum Age: 40 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Teva Branded Pharmaceutical Products R&D, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Expert, MD, Study Director, Teva Branded Pharmaceutical Products R&D, Inc.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.