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...