A single-centre, open-label, randomised, phase II study on the maintenance of ovulation inhibition after intentional application errors during 84 days of treatment with MR-130A-01 contraceptive transdermal patch

Condition studied

Investigation of maintenance of ovulation inhibition after intentional application errors for indication of contraception in healthy subjects

Investigational medicinal product(s)

Eligibility

Primary endpoint

Ovulation incidence in cycles with regular application, in cycles with 24h application errors & in cycles with 48h application errors. Ovulation is defined as Hoogland-Skouby score 5 or 6 in combination with positive Landgren criterion (i.e., rupture, or development into a luteinized unruptured follicle, of a follicle like structure > 13 mm, with concomitant estradiol [E2] concentrations >100 pmol/L & followed by a luteal phase with progesterone [P] concentrations > 16.0 nmol/L during ≥ 5 days

Endpoint detail

• Ovulation incidence overall • Ovulation incidence per treatment cycle, HSS determined for each treatment cycle, Fulfilment of Landgren criterion in cycles with HSS 5 or 6, FLS diameter and endometrial thickness determined by Transvaginal Ultrasonography (TVUS), Pituitary (luteinizing hormone [LH]) and ovarian (estradiol [E2], progesterone [P]) hormone concentrations in serum, Plasma concentration of NGMN and its metabolite norgestrel determined: immediately (5min) before and at the end of one scheduled patch-free window (once each per 24/48-hour application-error cycle), and immediately (5min) before application of a new patch (trough, once per regular-application cycle), Plasma concentrations of NGMN and norgestrel, Assessment of adhesion score by the participants themselves and by the site personnel, Safety and tolerability: treatment-emergent Adverse Events (TEAE); safety clinical laboratory parameters; incidence of application site reactions (skin irritation scores assessed by the participants), Bleeding pattern determined as incidences of bleeding and/or spotting episodes, number of observed days of bleeding and/or spotting, bleeding only and spotting only, incidences of complete absence of bleeding or spotting (excluding the first episode)