Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Diclofenac 1% · 1 trial · 1 indication
Evaluate the plasma pharmacokinetics of diclofenac after a single dose of DARE-PDM1
Evaluate the plasma pharmacokinetics of diclofenac after three doses of DARE-PDM1
Evaluate the vaginal fluid pharmacokinetics of diclofenac after three doses of DARE-PDM1
Evaluate the vaginal fluid pharmacokinetics of diclofenac after a single dose of DARE-PDM1
Compare genital safety of DARE-PDM1 versus placebo through vaginal exams
Evaluate systemic safety of DARE-PDM1 versus placebo through safety laboratory assessments
| Arm | Type | Description |
|---|---|---|
| DARE-PDM1 1% Diclofenac Vaginal Gel | EXPERIMENTAL | 1% Diclofenac in 2.5 mL Hydrogel |
| DARE-PDM1 3% Diclofenac Vaginal Gel | EXPERIMENTAL | 3% Diclofenac in 2.5 mL Hydrogel |
| Placebo | PLACEBO_COMPARATOR | 2.5 mL Hydrogel |
| Name | Type | Description |
|---|---|---|
| Diclofenac 1% | DRUG | vaginal hydrogel containing 1% Diclofenac |
| Diclofenac 3% | DRUG | vaginal hydrogel containing 3% Diclofenac |
| Placebo | DRUG | vaginal hydrogel, no active ingredient |
Inclusion Criteria: * Females ages 18- 50 years old (inclusive) * Self-assessment of historic dysmenorrhea associated pain level of ≥ 5 on a scale of 0 - 10 in at least one of the following anatomic sites: pelvic/vaginal pain, low back pain, while not using NSAIDs or hormonal contraception. * Non-p...
Diclofenac 1% is being developed for the treatment of primary dysmenorrhea, the menstrual pain that occurs without underlying pelvic disease. Dare Bioscience is studying it as a topical gel formulation in adult women. It is investigational and has not been approved for this use.
Diclofenac 1% is a small molecule inhibitor of the cyclooxygenase enzymes PTGS2 and PTGS1, also known as COX-2 and COX-1. By inhibiting these targets, it reduces prostaglandin production, which is the mechanism thought to drive the cramping pain of primary dysmenorrhea.
Dare Bioscience, Inc., which trades on the Nasdaq under the ticker DARE, is the developer of Diclofenac 1%. The company is evaluating the 1% diclofenac gel formulation in a clinical program focused on primary dysmenorrhea in women.
Diclofenac 1% is in Phase 1 clinical development. The program has completed one Phase 1 trial, and no trials are currently listed as active. It remains an investigational product and is not approved by the FDA for any indication.
Diclofenac 1% has been studied in one completed trial, NCT05752526, titled A Study of Diclofenac Gel in Women With Primary Dysmenorrhea. That Phase 1 trial enrolled 42 participants in Australia, was randomized, double blind, and placebo controlled, and included healthy female volunteers aged 18 years and older.