Bioequivalence of Estradiol/INTERMED 0.1% Gel versus ESTREVA 0.1% Gel in Healthy Postmenopausal Women: Open‑Label Randomized Single‑Dose Four‑Period Study

The trial enrolled healthy volunteers who were female; the specific age range was not disclosed. The sponsor did not provide the total number of participants. Selection was based on the absence of any therapeutic indication, indicating that participants were required to be in good general health without known medical conditions. No additional lifestyle restrictions or requirements such as diet or physical activity were specified, and the inclusion and exclusion criteria were limited to the healthy status of the volunteers.

The trial is an open, randomized, single‑dose, four‑period, full‑replicative Phase 2 study designed to assess bioequivalence of Estradiol/INTERMED gel 0.1% w/w versus ESTREVA 0.1% gel in healthy postmenopausal women. Participants undergo an initial screening visit to confirm eligibility, followed by four dosing periods separated by appropriate washout intervals; each period includes administration of the test or comparator product, a series of pharmacokinetic sampling visits, and safety assessments. After the final dosing period, an end‑of‑study visit is performed to complete final evaluations. The total involvement for each volunteer is approximately 4–5 weeks, encompassing the screening, dosing, washout, and follow‑up assessments. Early discontinuation may occur if a participant experiences a serious adverse event, violates protocol requirements, withdraws consent, or if investigational product supply is unavailable. The overall recruitment window spans from July 2026 to January 2027.