Overview

Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study

Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
0
Participant gender:
Female
Summary
Phase: I pharmacokinetic - pharmacodynamic (PK-PD) study. Main objective: To establish the minimum effective dose of progesterone microspheres suspension, which administered by weekly intramuscular injection, will be able to induce transformation from a proliferative endometrium to a secretory endometrium. Study design: Randomized, controlled, open-label, parallel, dose-response clinical trial. Sites: 1 Subjects: 48 postmenopausal women.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Productos Científicos S. A. de C. V.
Treatments:
Progesterone
Criteria
Inclusion Criteria:

- Female

- 45 to 60 years old

- Able to read and write

- Postmenopausal

- Body Mass Index equal or below 34.99 kg/m2

- Healthy

- Normal uterus

- Time availability

Exclusion Criteria:

- Hypersensitivity to progesterone or related compounds

- Hypersensitivity to estrogens

- Hysterectomy

- History or present hormone-dependent tumor

- History or present uterine cervix dysplasia

- Abnormal and clinically-significant laboratory test results

- Family history of breast cancer

- History of thromboembolic disease

- Non-controlled hypertension

- History of stroke

- History of cardiac valve surgery

- Renal failure

- Hepatic failure

- Non-controlled diabetes

- Severe gastrointestinal disease

- History of serious neurologic disease

- Reduced mobility

- Anemia

- Previous or concomitant hormonal therapy

- Previous or concomitant therapy with inhibitors or inductors of cytochrome