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

S

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)

240 participants in 2 patient groups

1
Experimental group
Treatment:
Drug: PROMETRIUM® 300 mg
2
Active Comparator group
Treatment:
Drug: PROMETRIUM® 400 mg

Trial contacts and locations

42

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Data sourced from clinicaltrials.gov

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