CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 240 enrolled
Drug / intervention
PROMETRIUM® 300 mg +1 moredrug
Likely dose
300 mg or 400 mg orally once daily at bedtime for 10 days × 3 cyclesAI-extracted
Key inclusion· 2
  • ✓Women with secondary amenorrhea
  • ✓Normal serum DHEA, prolactin, testosterone, TSH, and thyroxine
Key exclusion· 4
  • ✕Primary amenorrhea
  • ✕Other medical conditions resulting in amenorrhea (e.g., Asherman's syndrome)
  • ✕Peanut allergy
  • ✕Allergy to progestational steroids

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00160199
NCT00160199Phase 4Completed
CompareCT.gov

Evaluation of Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding in Subjects With Secondary Amenorrhea

Solvay Pharmaceuticals·interventional·Posted Sep 12, 2005·Updated Jul 7, 2010

In Brief

A Phase 4 clinical trial evaluating PROMETRIUM® 300 mg and PROMETRIUM® 400 mg for Secondary Amenorrhea. Completed, enrolled 240 participants across 42 sites.

Detailed Summary

To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Amenorrhea
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartNov 1, 2004
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.8 years ago

Interventions

PROMETRIUM® 300 mgdrug

300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles

PROMETRIUM® 400 mgdrug

400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles