Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion - Full Text View

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00160199

Purpose

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

Condition	Intervention	Phase
Secondary Amenorrhea	Drug: PROMETRIUM® 300 mg Drug: PROMETRIUM® 400 mg	Phase IV

Drug Information available for: Progesterone

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding in Subjects With Secondary Amenorrhea

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Induction of complete secretory conversion of the endometrium and rate of withdrawal bleeding measured [ Time Frame: 3 28-day cycles ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Frequency and intensity of withdrawal bleeding [ Time Frame: From termination of PROMETRIUM® therapy up to and including one week following the last dose for 3 28-day cycles ] [ Designated as safety issue: Yes ]
Number of days from last dose of study medication to the initiation of withdrawal bleeding [ Time Frame: From last dose of study medication to inititation of withdrawal bleeding ] [ Designated as safety issue: Yes ]
Intensity of withdrawal bleeding episode [ Time Frame: Duration of withdrawal bleed ] [ Designated as safety issue: Yes ]
The duration of withdrawal bleeding episode [ Time Frame: Duration of withdrawal bleed ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	216
Study Start Date:	September 2004
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: PROMETRIUM® 300 mg 300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
2: Active Comparator	Drug: PROMETRIUM® 400 mg 400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160199

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

Responsible Party:	Solvay Pharmaceuticals ( Cindy Lane )
Study ID Numbers:	S168.4.002
Study First Received:	September 8, 2005
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00160199
Health Authority:	United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

To collect additional data on 300 and 400 mg doses of PROMETRIUM in women with secondary amenorrhea

Study placed in the following topic categories:

Progesterone
Menstruation Disturbances
Amenorrhea
Neoplasm Metastasis
Hemorrhage

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes
Progestins

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009