PharmacokineticsPhase 1NCT02092571
A Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings in Postmenopausal Women
A Phase 1 study testing Progesterone vaginal ring, in people with Pharmacokinetics, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
Trial summary
A study to assess the pharmacokinetics of 2 progesterone vaginal rings in postmenopausal women Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Progesterone vaginal ring,
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
- 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
- The subject has a vaginal ultrasonography at screening that confirms an active endometrial lining and/or an endometrial thickness of ≥4 mm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
A study to assess the pharmacokinetics of 2 progesterone vaginal rings in postmenopausal women
- Conditions
- Pharmacokinetics
- Being tested
- Progesterone vaginal ring,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone vaginal ring,Drug
Also called 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
Participants will be randomized to receive treatments in 1 of 2 treatment sequences (AB or BA)
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 1 ring intravaginal for 7 days, produced from the new process Receives: Drug: Progesterone vaginal ring, |
| Treatment B | Experimental | 1 ring intravaginal for 7 days, produced from the legacy process Receives: Drug: Progesterone vaginal ring, |
What is being measured
The primary outcome is the main question the study is designed to answer.
baseline-adjusted AUCt
Measured: 16 weeks
baseline-adjusted AUC∞
Measured: 16 weeks
baseline-adjusted Cmax
Measured: 16 weeks
Secondary outcomes (9)
baseline-adjusted tmax
Measured: 16 weeks
baseline-unadjusted AUCt
Measured: 16 weeks
baseline-adjusted λz
Measured: 16 weeks
baseline-adjusted t½
Measured: 16 weeks
baseline-unadjusted AUC∞
Measured: 16 weeks
baseline-unadjusted Cmax
Measured: 16 weeks
baseline-unadjusted tmax
Measured: 16 weeks
baseline-unadjusted λz
Measured: 16 weeks
baseline-unadjusted t½
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092571
- Sponsor's protocol ID
- DR201-BE-10021
- Status last verified
- Nov 2021
- First submitted
- 28 Feb 2014
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02092571
- Acronym / sponsor ID
- DR201-BE-10021
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to assess the pharmacokinetics of 2 progesterone vaginal rings in postmenopausal women
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Progesterone vaginal ring,1 ring intravaginal for 7 days, produced from the new process |
| Treatment B | Experimental | Drug: Progesterone vaginal ring,1 ring intravaginal for 7 days, produced from the legacy process |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progesterone vaginal ring,Also: 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 processParticipants will be randomized to receive treatments in 1 of 2 treatment sequences (AB or BA) | Drug | Treatment A, Treatment B |
Primary outcome
baseline-adjusted AUCt
Time frame: 16 weeks
baseline-adjusted AUC∞
Time frame: 16 weeks
baseline-adjusted Cmax
Time frame: 16 weeks
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Progesterone vaginal ring, in people with Pharmacokinetics, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
baseline-adjusted AUCt (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.