Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01176175
• Date of registration: 04/08/2010
• Prospective Registration: No
• Primary sponsor: Productos Científicos S. A. de C. V.
• Public title: Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study
• Scientific title: Randomized, Controlled, Open-label, Parallel, Clinical Trial to Assess Pharmacokinetics and Endometrial Effect of an Injectable Formulation of Progesterone Microspheres in Doses of 50 mg, 100 mg, 200 mg and 300 mg, in Postmenopausal Women.
• Date of first enrolment: August 2010
• Target sample size: 48
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01176175
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Mexico

Contacts

• Name: Roberto Bernardo, MD MSc
• Affiliation: Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)

Key inclusion & exclusion 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



Age minimum: 45 Years
Age maximum: 60 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Infertility

Intervention(s)

Drug: Progesterone

Primary Outcome(s)

Endometrial dating through histopathologic criteria. [Time Frame: 10 days]

Secondary Outcome(s)

Pharmacokinetics [Time Frame: 0 -60 days.]

Adverse events [Time Frame: 0 - 65 days]

Secondary ID(s)

0908/I/PRO

Source(s) of Monetary Support

Please refer to primary and secondary sponsors