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
Ovulation inhibition study of MR-130A-01 contraceptive transdermal patch containing norelgestromin with intentional application errors; MR-130A-01-TD-2002
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)
dinox GmbH
Berlin, Germany
RECRUITINGOvulation incidence in cycle with regular application, and in cycles with extended period application errors. Ovulation is defined as a Hoogland-Skouby score 5 or 6 in combination with fulfilment of Landgren criterion.
Time frame: 84 days
Ovulation incidence overall and incidence per treatment cycle.
Time frame: 84 days
HSS determined for each treatment cycle.
Time frame: 84 days
Fulfilment of Landgren criterion in cycles with HSS 5 or 6.
Time frame: 84 days
FLS diameter and endometrial thickness determined by transvaginal ultrasound (TVUS).
Time frame: 84 days
Pituitary (luteinizing hormone [LH]) and ovarian (estradiol [E2], progesterone [P]) hormone concentrations in serum.
Time frame: 84 days
Plasma concentration of NGMN and its metabolite norgestrel Immediately 5min before and at the end of one scheduled patch-free window.
Time frame: 84 days
Plasma concentrations of NGMN and norgestrel.
Time frame: 84 days
Assessment of adhesion score by the participants themselves and by the site personnel.
Time frame: 84 days
Safety and tolerability: Treatment-emergent Adverse Events (TEAE) Safety clinical laboratory parameters Incidence of application site reactions (skin irritation scores assessed by the participants).
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Time frame: 84 days
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).
Time frame: 84 days