Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study

Infertility Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176175
• Other study ID #: 0908/I/PRO
• Status: Completed
• Phase: Phase 1
• First received: August 4, 2010
• Last updated: October 12, 2011
• Start date: August 2010
• Est. completion date: February 2011

Study information

• Verified date: October 2011
• Source: Productos Científicos S. A. de C. V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Sites: 1 Phase: 1 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.

Secondary objectives:

• To determine and compare the steady-state pharmacokinetic profile of investigational products.

• To evaluate safety profile of investigational products in the study subjects.

• To evaluate local tolerability of investigational products in the study subjects.

Study design:Randomized, controlled, open-label, parallel, dose-response clinical trial.

Investigational products:

• Progesterone microspheres intramuscular injectable suspension 50 mg

• Progesterone microspheres intramuscular injectable suspension 100 mg

• Progesterone microspheres intramuscular injectable suspension 200 mg

• Progesterone microspheres intramuscular injectable suspension 300 mg Study subjects: 48 healthy postmenopausal women, 45 - 60 years. Brief description: After written informed consent, 48 eligible women will receive pretreatment with oral estradiol valerate, then, 14 days later, those with adequate endometrial thickness evaluated through ultrasound will be randomized to study treatments (one IM injection each 7 days, for a total of 7 doses). 10 days after the first progesterone dose, an endometrial biopsy will be obtained. Blood samples will be obtained for pharmacokinetic study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Progesterone
Progesterone microspheres injectable suspension 50 mg, intramuscular weekly injection for a total of 7 doses.
• Progesterone
Progesterone microspheres injectable suspension 100 mg, intramuscular weekly injection for a total of 7 doses.
• Progesterone
Progesterone microspheres injectable suspension 200 mg, intramuscular weekly injection for a total of 7 doses.
• Progesterone
Progesterone microspheres injectable suspension 300 mg, intramuscular weekly injection for a total of 7 doses.

Locations

Country	Name	City	State
Mexico	Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)	Pachuca	Hidalgo

Sponsors (1)

Lead Sponsor	Collaborator
Productos Científicos S. A. de C. V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial dating through histopathologic criteria.	Endometrial dating according Noyes criteria as a measure of efficacy. At the moment of the biopsy, study subjects would have received 25 days of estradiol valerate pretreatment and 10 days of progesterone (investigational product); thus simulating the 25th day of a menstrual cycle. Efficacy will be measured as number of biopsies that have histological date according to cronological date.	10 days	No
Secondary	Pharmacokinetics	Progesterone plasmatic concentrations and pharmacokinetic parameters.	0 -60 days.	No
Secondary	Adverse events	Number of Participants with Adverse Events as a Measure of Safety and Tolerability Pain Scores on a Visual Analog Scale	0 - 65 days	Yes