Endometrial Effects of Daily Progesterone s.c. 25 and 50 Mg Aqueous Formulation to Female Healthy Volunteers

September 19, 2006 updated by: IBSA Institut Biochimique SA
This is a multiple dose, observer blind, randomised, parallel groups pharmacodynamic and pharmacokinetic study to assess the endometrial effects (predecidual changes) of a new aqueous progesterone formulation administered s.c. at the dose of 25 and 50 mg/day.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed in order to assess the efficacy of the investigational product (Progesterone acqueous s.c. formulation) when it is administered at the dose of 25 and 50 mg. The induced predecidual changes will be evaluated through endometrial bioptic samplings, performed on day 11 and will be compared between the two treatment groups.

The pharmacokinetic evaluation was designed according to internationally recognised guidelines for PK studies.

Study Type

Interventional

Enrollment

24

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • BMI: 19</=BMI</=25 kg/m2;
  • Proper estrogen priming; absence of progesterone exposure prior to exogenous progesterone administration;
  • normal pelvic ultrasound;
  • absence of active follicular growth following initiation of E2 treatment;
  • Complete suppression of ovarian function;
  • Vital signs: SBP 100-139 mmHg, DBP 50-89, HR 50-90 bpm;
  • Full comprehension of the nature and purpose of the study and possible risks and side effects;
  • signed written informed consent prior to inclusion in the study

Exclusion Criteria:

  • pregnant or lactating women;
  • ECG: clinically relevant abnormalities;
  • clinical relevant abnormal physical findings which could interfere with the objectives of the study;
  • clinical relevant abnormal laboratory values indicative of physical illness, ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients;
  • history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study;
  • history of uterine pathologies (fibroids, polyps, adenomyosis, etc), history of dysfunctional bleeding, relevant history of renal, hepatic, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, history of neoplasias (genital apparatus, breast, liver or hormone-dependent cancer) severe liver failure, acute or chronic liver dysfunction, cholestatic jaundice, hypertension, thrombo-phlebitis, thrombo-embolism, cerebro-vascular insult or severe depression; medication, including OTC, during 2 weeks before the start of the study;
  • participation in the evaluation of any drug within 1 month prior to the start of the study;
  • blood donations during the 1 month prior to this study;
  • history of drug, alcohol [>1 drink/day defined according to USDA Dietary Guidelines 2005 (18)] caffeine (>5 cups/ day of coffee or tea) or tobacco abuse (≥10 cigarettes/day);
  • Abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits within the past 4 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
partial and full predecidual changes in endometrial samples on the 11th day of exposure to the IMP compared to the findings on the 11th day after ovulation in the menstrual cycle, according to Noyes criteria

Secondary Outcome Measures

Outcome Measure
PK profile of progesterone at the steady-state following the 25 or 50 mg/day of progesterone s.c. at the time of endometrial biopsy, local tolerability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IBSA Institut Biochimique SA

Investigators

  • Principal Investigator: Markus Müller, Prof, Department of Clinical Pharmacology, AKH, Vienna, Austria.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

September 18, 2006

First Submitted That Met QC Criteria

September 18, 2006

First Posted (Estimate)

September 19, 2006

Study Record Updates

Last Update Posted (Estimate)

September 20, 2006

Last Update Submitted That Met QC Criteria

September 19, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05A/Prg05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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