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Proellex Pharmacokinetics Bridging Study

R

Repros Therapeutics

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: 50 mg Proellex
Drug: 25 mg Proellex

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations

Full description

Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations (24 and 50 mg dose). Blood was collected pre-dose, at specified intervals and 24 hours post dose. Each dose was separated by at least one week interval from the previous dose.

Enrollment

21 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the clinical Investigator
  • Subject was willing to remain in the clinic for the screening visit; and for the treatment visits (day -1, day of treatment and day 1; approximately 36 hrs per treatment visit)

Exclusion criteria

  • Post-menopausal women,
  • Subject with documented endometriosis
  • Subject with known uterine fibroids or vaginal polyps

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

21 participants in 4 patient groups

Proellex Formulation 1
Experimental group
Description:
25 mg Proellex Gelucire and PEG (original formulation)
Treatment:
Drug: 25 mg Proellex
Drug: 25 mg Proellex
Drug: 25 mg Proellex
25 mg Proellex Formulation 2
Experimental group
Description:
25 mg Proellex coated with MCC
Treatment:
Drug: 25 mg Proellex
Drug: 25 mg Proellex
Drug: 25 mg Proellex
25 mg Proellex Formulation 3
Experimental group
Description:
25 mg Proellex blended with MCC
Treatment:
Drug: 25 mg Proellex
Drug: 25 mg Proellex
Drug: 25 mg Proellex
50 mg Proellex Formulation 3
Experimental group
Description:
50 mg Proellex blended with MCC
Treatment:
Drug: 50 mg Proellex

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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