At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 108 enrolled
Drug / intervention
FE 999913 vaginal tabletdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Randomized, Open-Label, Parallel Group Study of FE 999913 Vaginal Tablet 100 mg in Japanese Female Patients Undergoing Fertility Treatment [In Vitro Fertilization/Embryo Transfer (IVF-ET)]
In Brief
A Phase 3 clinical trial evaluating FE 999913 vaginal tablet for Luteal Hormone Supplementation. Completed, enrolled 108 participants across 6 sites.
Detailed Summary
The purposes of the study are to verify sufficient supplementation of luteal hormone after administrating FE999913 Vaginal Tablet twice a day (BID) or three times a day (TID) and to determine the efficacy and safety of FE999913 Vaginal Tablet in Japanese women undergoing fertility treatment with IVF-ET (a fresh embryo transfer).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLuteal Hormone Supplementation
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedOct 2012
Primary CompletionAug 2013
TodayJul 2026
First PostedOct 19, 2012
Enrollment StartOct 1, 2012
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.7 years ago
Interventions
FE 999913 vaginal tabletdrug