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

Solvay

Status and phase: Completed; Phase 4

Conditions: Secondary Amenorrhea

Treatments: Drug: PROMETRIUM® 300 mg; Drug: PROMETRIUM® 400 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160199

S168.4.002

Details and patient eligibility

About

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

Enrollment: 240 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: PROMETRIUM® 300 mg

2

Active Comparator group

Treatment:

Drug: PROMETRIUM® 400 mg