Last reviewed · How we verify
NCT06668896
An Open-Label, Four-Treatment, Parallel Study of the Comparative Pharmacokinetics of a Progesterone Intravaginal Ring (IVR) 8 mg and 12 mg/Day Versus Progesterone Vaginal Insert 100mg
Phase 1 trial testing Progesterone in Pre Term Birth in 60 participants. Not yet recruiting.
1 November 2027
Quick facts
| Lead sponsor | Daré Bioscience, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 September 2026 |
| Primary completion | 1 November 2027 |
| Estimated completion | 1 April 2028 |
Drugs / interventions tested
- Progesterone (Progesterone plus HCG) — full drug profile →
Conditions studied
- Pre Term Birth — all drugs for Pre Term Birth →
Sponsor
Daré Bioscience, Inc. — full company profile →
Who can join
Adults 40 to 65, female only, with Pre Term Birth. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Systemic pharmacokinetics of progesterone, Concentration over 24 hours
Time frame: 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.
Sponsor's own description
This study is looking for healthy female adults to use an vaginal ring with differing amounts of the hormone progesterone and go through a series of blood draws to measure how much progesterone is in the body following the use of these vaginal rings over an extended period of time.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06668896
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Progesterone
Trials testing the same drug.
- NCT07372495 — Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix · NA · not yet recruiting
- NCT06631547 — Effect of Progesterone Administration on Severely Head Injured Patients · Phase 1 · not yet recruiting
- NCT07162961 — Nintedanib for Improving Reproductive Outcomes in Adenomyosis · Phase 3 · not yet recruiting
- NCT06851754 — Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency · Phase 3 · recruiting
- NCT06928844 — Role of Low Dose Injectable Progesterone in Triggering Ovulation · NA · recruiting
Other Daré Bioscience, Inc. trials
Trials by the same sponsor.
- NCT05752526 — A Study of Diclofenac Gel in Women With Primary Dysmenorrhea · Phase 1 · completed
- NCT05765487 — Using Thermography to Assess the Affects of Sildenafil Cream, 3.6% · Phase 1 · completed
- NCT05367973 — Study of DARE-HRT1 Over 12 Weeks in Healthy PostMenopausal Women · Phase 1, PHASE2 · completed
- NCT05378269 — Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA · Phase 1, PHASE2 · completed
- NCT05354050 — Pharmacokinetic Study of DARE-BV1 · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06668896 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Daré Bioscience, Inc.
- Last refreshed: 7 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06668896.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing