At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Double-blind, Double-dummy, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of SH T00658ID Compared to SH D593B in the Treatment of Primary Dysmenorrhea
In Brief
A Phase 3 clinical trial evaluating Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027), Ethinyl estradiol, Levonorgestrel (Miranova), and 2 other interventions for Primary Dysmenorrhea. Completed, enrolled 507 participants across 41 sites in 6 countries.
Detailed Summary
To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.
Study Details
Timeline
Interventions
Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval
Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval
Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.