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Progesterone vaginal ring

Phase 1

Pharmacokinetics | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Nov 9, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

Progesterone vaginal ring · 1 trial · 1 indication

Phase 1 1
NCT02092571A Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings in Postmenopausal WomenPharmacokinetics
COMPLETED56 Analytics
PHASE1COMPLETED
A Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings in Postmenopausal Women
Pharmacokinetics
NCT0209257156
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Study Endpoints

Primary Endpoints

baseline-adjusted AUCt
16 weeks
baseline-adjusted AUC∞
16 weeks
baseline-adjusted Cmax
16 weeks

Secondary Endpoints

baseline-adjusted tmax
16 weeks
baseline-unadjusted AUCt
16 weeks
baseline-adjusted λz
16 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTAL1 ring intravaginal for 7 days, produced from the new process
Treatment BEXPERIMENTAL1 ring intravaginal for 7 days, produced from the legacy process

Interventions

NameTypeDescription
Progesterone vaginal ring,DRUGParticipants will be randomized to receive treatments in 1 of 2 treatment sequences (AB or BA)
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Eligibility Criteria

Age Range40 Years to 70 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Frequently asked questions about Progesterone vaginal ring

What is Progesterone vaginal ring used for?

Progesterone vaginal ring is an investigational small molecule product being studied for pharmacokinetics, specifically to evaluate the bioequivalence of two progesterone vaginal rings in postmenopausal women. It is currently in Phase 1 clinical development and is not approved for any indication.

Who makes Progesterone vaginal ring?

Progesterone vaginal ring is being developed by Teva Pharmaceutical Industries Limited, traded on the stock exchange under the ticker TEVA. The company is conducting clinical research to evaluate the product's pharmacokinetic profile in postmenopausal women.

What phase is Progesterone vaginal ring in?

Progesterone vaginal ring is in Phase 1 clinical development. A single Phase 1 study has been completed, and the product remains investigational. It has not been approved by regulatory authorities for any use.

What clinical trials is Progesterone vaginal ring in?

Progesterone vaginal ring has one completed clinical trial, NCT02092571, titled 'A Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings in Postmenopausal Women.' This Phase 1 study enrolled 56 healthy female volunteers aged 40 years and older in the United States.

How does Progesterone vaginal ring work?

Progesterone vaginal ring delivers progesterone, a hormone, locally through vaginal administration. The ongoing clinical study evaluates the pharmacokinetics and bioequivalence of two formulations of the ring in postmenopausal women, focusing on how the drug is absorbed and processed by the body.