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Progesterone

Phase 4FDA approved

Pre Term Birth | Small molecule | Other |Dare Bioscience, Inc.|Trials Updated: May 8, 2026

Progesterone development status

FDA approval on record Sep 17, 2001
Approval holderLilly
ApplicationNDA009238
Highest phase Phase 4 run by Kronos Longevity Research Institute (NCT00154180)
Phase scored for DAREPhase 1
Registered trials 25 across 15 sponsors since Sep 2005

Progesterone target and mechanism

Molecular targetPGR
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL103

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Progesterone clinical trials

Progesterone · 1 trial · 1 indication

Phase 1 1
NCT06668896Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal InsertPre Term Birth
NOT YET_RECRUITING60 Analytics
PHASE1NOT YET_RECRUITING
Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert
Pre Term BirthUnlock trial analytics

Study Endpoints

Primary Endpoints

Systemic pharmacokinetics of progesterone, Concentration over 24 hours
14 days

Describe the concentration of progesterone (P4) in blood prior to, during and after 24 hours of DARE-PTB1 IVR (8mg and 12mg) over 14 days of use.

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DARE-PTB1 8mg IVREXPERIMENTALIntravaginal ring containing 8mg progesterone administered once for 14 days.
DARE-PTB1 12mg IVREXPERIMENTALIntravaginal ring containing 12mg progesterone administered once for 14 days.
DARE-PTB1 12mg IVR every 3 daysEXPERIMENTALIntravaginal ring containing 12mg progesterone administered every 3 days for 15 days.
Endometrin 100mgACTIVE_COMPARATOR100mg progesterone vaginal insert, three times daily for 14 days.

Interventions

NameTypeDescription
ProgesteroneDRUGEach arm will administer different amounts of progesterone vaginally (8mg to 100mg) over a 14-15 day time period.
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Eligibility Criteria

Age Range40 Years to 65 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Individuals assigned female at birth who are post-menopausal, women 40 to 65 years of age, inclusive. Postmenopausal is defined as 6-months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL (if not taking systemic hormone therapy) or 6 weeks postsurgical bilateral o...

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Frequently asked questions about Progesterone

What is Progesterone used for in Pre Term Birth?

Progesterone is being developed by Dare Bioscience, Inc. for the prevention of Pre Term Birth. It is a small molecule drug that acts as an agonist of the PGR (progesterone receptor) target. The drug is currently in Phase 1 clinical development and is being studied in a clinical trial to compare its pharmacokinetics.

What does Progesterone target?

Progesterone targets the PGR (progesterone receptor) and acts as an agonist. This means it binds to and activates the progesterone receptor, which is involved in maintaining pregnancy. The drug is being studied for its potential to prevent Pre Term Birth.

Who makes Progesterone?

Progesterone is being developed by Dare Bioscience, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug for the prevention of Pre Term Birth. Dare Bioscience, Inc. is listed on the stock exchange under the ticker symbol DARE.

What phase is Progesterone in?

Progesterone is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is designed to study the drug's pharmacokinetics in healthy volunteers.

What clinical trials is Progesterone in?

Progesterone is being studied in a Phase 1 clinical trial with the identifier NCT06668896. The trial is titled 'Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert' and is expected to enroll 60 female participants aged 40 years and older. The trial is not yet recruiting.

Is Progesterone the same as other progesterone products?

Progesterone is a naturally occurring hormone and is the active ingredient in various pharmaceutical products. The drug being developed by Dare Bioscience, Inc. is a specific formulation of progesterone, and the ongoing clinical trial is comparing a progesterone ring to a progesterone vaginal insert.