Phase 4
N=240
Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion
Secondary Amenorrhea
Bottom Line
View on ClinicalTrials.gov: NCT00160199 ↗Enrolled (actual)
240
Serious AEs
1.4%
Results posted
Jun 2010
Primary outcome: Primary: Secretory Conversion of the Endometrium — 23; 28; 70; 53 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- PROMETRIUM® 300 mg (Drug); PROMETRIUM® 400 mg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Solvay Pharmaceuticals
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Secretory Conversion of the Endometrium |
23; 28; 70; 53; 7; 9 | — |
| PRIMARY Number of Subjects With Withdrawal Bleeding |
93; 90 | — |
| SECONDARY Maximum Intensity of Withdrawal Bleeding After Any Cycle |
13; 8; 10; 3; 18; 14 | — |
| SECONDARY The Duration of Withdrawal Bleeding After the First Treatment Cycle |
4.0; 3.8 | — |
| SECONDARY The Duration of Withdrawal Bleeding After Second Treatment Cycle |
3.5; 3.8 | — |
| SECONDARY Time to Withdrawal Bleeding After First Treatment Cycle |
1.9; 2.2 | — |
| SECONDARY Time to Withdrawal Bleeding After Second Treatment Cycle |
1.6; 2.21 | — |
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
Eligibility Criteria
Inclusion Criteria
- Women with secondary amenorrhea
- Normal serum Dehydroepiandrosterone (DHEA), prolactin, testosterone, Thyroid Stimulating Hormone (TSH) and thyroxine
Exclusion Criteria
- Primary amenorrhea
- Other medical conditions resulting in amenorrhea (e.g. Asherman's syndrome)
- Peanut allergy
- Allergy to progestational steroids
Data sourced from ClinicalTrials.gov (NCT00160199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.