Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion

NCT00160199 | Completed Phase 4 Results

• 1 other identifier: S168.4.002
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 42

Brief 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

Conditions

Secondary Amenorrhea

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Secretory Conversion of the Endometrium

  Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.

  End of the study (Days 85)

• Number of Subjects With Withdrawal Bleeding

  This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle.

  After first and second cycle (cycle=28 days)

Secondary Outcomes (5)

• Maximum Intensity of Withdrawal Bleeding After Any Cycle

  Duration of withdrawal bleed

• The Duration of Withdrawal Bleeding After the First Treatment Cycle

  End of the first cycle of treatment (cycle=28 days)

• The Duration of Withdrawal Bleeding After Second Treatment Cycle

  End of the second cycle of treatment (cycle=28 days)

• Time to Withdrawal Bleeding After First Treatment Cycle

  End of the first cycle of treatment (cycle=28 days)

• Time to Withdrawal Bleeding After Second Treatment Cycle

  End of the second cycle of treatment (cycle=28 days)

Study Arms (2)

1

EXPERIMENTAL

Drug: PROMETRIUM® 300 mg

2

ACTIVE COMPARATOR

Drug: PROMETRIUM® 400 mg

Interventions

PROMETRIUM® 300 mg DRUG

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

1

PROMETRIUM® 400 mg DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with secondary amenorrhea
• Normal serum Dehydroepiandrosterone (DHEA), prolactin, testosterone, Thyroid Stimulating Hormone (TSH) and thyroxine

You may not qualify if:

• Primary amenorrhea
• Other medical conditions resulting in amenorrhea (e.g. Asherman's syndrome)
• Peanut allergy
• Allergy to progestational steroids

Sponsors & Collaborators

• Solvay Pharmaceuticals: lead

Study Sites (42)

Site 29

Mobile, Alabama, United States

Location

Site 41

Montgomery, Alabama, United States

Location

Site 26

Tucson, Arizona, United States

Location

Site 5

Jonesboro, Arkansas, United States

Location

Site 39

Carmichael, California, United States

Location

Site 17

Encinitas, California, United States

Location

Site 10

San Diego, California, United States

Location

Site 42

Avon, Connecticut, United States

Location

Site 3

Groton, Connecticut, United States

Location

Site 22

New Britian, Connecticut, United States

Location

Site 9

Waterbury, Connecticut, United States

Location

Site 37

West Hartford, Connecticut, United States

Location

Site 14

Aventura, Florida, United States

Location

Site 40

Clearwater, Florida, United States

Location

Site 1

West Palm Beach, Florida, United States

Location

Site 30

West Palm Beach, Florida, United States

Location

Site 46

Atlanta, Georgia, United States

Location

Site 43

Powder Springs, Georgia, United States

Location

Site 36

Champaign, Illinois, United States

Location

Site 12

Chicago, Illinois, United States

Location

Site 6

Baton Rouge, Louisiana, United States

Location

Site 7

Baltimore, Maryland, United States

Location

Site 2

St Louis, Missouri, United States

Location

Site 16

Reno, Nevada, United States

Location

Site 45

New York, New York, United States

Location

Site 23

New Bern, North Carolina, United States

Location

Site 15

Winston-Salem, North Carolina, United States

Location

Site 28

Winston-Salem, North Carolina, United States

Location

Site 33

Cincinnati, Ohio, United States

Location

Site 32

Erie, Pennsylvania, United States

Location

Site 47

Hershey, Pennsylvania, United States

Location

Site 44

Philadelphia, Pennsylvania, United States

Location

Site 38

Pottstown, Pennsylvania, United States

Location

Site 13

Greenville, South Carolina, United States

Location

Site 8

Conroe, Texas, United States

Location

Site 11

Corpus Christi, Texas, United States

Location

Site 27

Houston, Texas, United States

Location

Site 34

Houston, Texas, United States

Location

Site 24

San Antonio, Texas, United States

Location

Site 35

Salt Lake City, Utah, United States

Location

Site 19

Norfolk, Virginia, United States

Location

Site 4

Seattle, Washington, United States

Location

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Results Point of Contact

• Title: Sven Voet - Global Communication
• Organization: Solvay Pharmaceuticals

sven.voet@solvay.com

+32(0)2 509 69 77

Study Officials

• Global Clinical Director Solvay

  Solvay Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: November 1, 2004
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 7, 2010
• Results First Posted: June 2, 2010

Record last verified: 2010-06

Locations

US (42)