Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study

• Sponsor: Productos Científicos S. A. de C. V. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01176175
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 4
• Duration (Months): 6
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Progesterone; Drug: Progesterone; Drug: Progesterone; Drug: Progesterone	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 50 mg Progesterone microspheres injectable suspension 50 mg	Drug: Progesterone; Progesterone microspheres injectable suspension 50 mg, intramuscular weekly injection for a total of 7 doses.
Experimental: 100 mg Progesterone microspheres injectable suspension 100 mg	Drug: Progesterone; Progesterone microspheres injectable suspension 100 mg, intramuscular weekly injection for a total of 7 doses.
Experimental: 200 mg Progesterone microspheres injectable suspension 200 mg	Drug: Progesterone; Progesterone microspheres injectable suspension 200 mg, intramuscular weekly injection for a total of 7 doses.
Experimental: 300 mg Progesterone microspheres injectable suspension 300 mg	Drug: Progesterone; Progesterone microspheres injectable suspension 300 mg, intramuscular weekly injection for a total of 7 doses.

Outcome Measures

Primary Outcome Measures

1. Endometrial dating through histopathologic criteria. [10 days]

   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.

Secondary Outcome Measures

1. Pharmacokinetics [0 -60 days.]

   Progesterone plasmatic concentrations and pharmacokinetic parameters.

2. Adverse events [0 - 65 days]

   Number of Participants with Adverse Events as a Measure of Safety and Tolerability Pain Scores on a Visual Analog Scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)	Pachuca	Hidalgo	Mexico	42090

Sponsors and Collaborators

• Productos Científicos S. A. de C. V.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roberto Bernardo Escudero, Principal Investigator, Productos Científicos S. A. de C. V.
• ClinicalTrials.gov Identifier: NCT01176175
• Other Study ID Numbers: 0908/I/PRO
• First Posted: Aug 5, 2010
• Last Update Posted: Oct 13, 2011
• Last Verified: Oct 1, 2011

• Keywords provided by Roberto Bernardo Escudero, Principal Investigator, Productos Científicos S. A. de C. V.: Progesterone; Microspheres; postmenopausal; Luteal phase support
• Additional relevant MeSH terms: Infertility; Progesterone

Study Results

No Results Posted as of Oct 13, 2011