Comparative Bioavailability of Two Injectable Suspension Formulations of Medroxyprogesterone Acetate+Estradiol Cypionate

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

March 31, 2017

Primary Completion Date

April 2, 2017

Study Completion Date

August 1, 2017

Conditions
Contraception
Interventions
DRUG

Test formulation

Administration of a single intramuscular dose of an injectable formulation containing medroxyprogesterone acetate 25 mg/mL + estradiol cypionate 5 mg/mL after an overnight fast.

DRUG

Reference formulation

Administration of a single intramuscular dose of an injectable formulation containing medroxyprogesterone acetate 25 mg/ampole + estradiol cypionate 5 mg/ampole after an overnight fast.

Trial Locations (1)

Unknown

Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME, Campinas

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Biolab Sanus Farmaceutica

INDUSTRY

lead

Galeno Desenvolvimento de Pesquisas Clínicas

OTHER_GOV