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Progesterone vaginal ring

Phase 1

Undisclosed | Small molecule | Other |Teva Pharmaceutical Industries Limited|Trials Updated: Nov 9, 2021

Progesterone vaginal ring development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2014

Progesterone vaginal ring target and mechanism

Molecular targetPGR
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL103

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Progesterone vaginal ring clinical trials

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
PharmacokineticsUnlock trial analytics

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?

Progesterone vaginal ring is an investigational small molecule therapeutic developed by Teva Pharmaceutical Industries Limited. It is designed to deliver progesterone through a vaginal ring dosage form. The specific medical indication for this product has not been publicly disclosed, and the program remains in Phase 1 clinical development.

What does progesterone vaginal ring target?

Progesterone vaginal ring targets the progesterone receptor, also known as PGR, where it acts as an agonist. By binding and activating PGR, the ring delivers a progestational effect through the vaginal route. This receptor is the same biological target engaged by other progesterone-based therapies.

Who makes progesterone vaginal ring?

Progesterone vaginal ring is being developed by Teva Pharmaceutical Industries Limited, which trades on the New York Stock Exchange under the ticker TEVA. Teva is the sponsor responsible for the clinical development program for this investigational product.

What phase is progesterone vaginal ring in?

Progesterone vaginal ring is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The program has completed one Phase 1 trial, and no active trials are currently listed for this asset.

What clinical trials is progesterone vaginal ring in?

Progesterone vaginal ring has been studied in one completed Phase 1 trial, NCT02092571, titled A Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings in Postmenopausal Women. The trial enrolled 56 female participants aged 40 years and older in the United States and was randomized and controlled.

Is progesterone vaginal ring the same as other progesterone products?

Progesterone vaginal ring is also referred to simply as progesterone vaginal ring. It is a distinct investigational vaginal ring formulation developed by Teva, not a generic oral progesterone product. Its identity is defined by the vaginal ring delivery system and the specific pharmacokinetic profile studied in NCT02092571.