|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01190475 |
|
Date of registration:
|
19/08/2010 |
|
Primary sponsor: |
|
|
Public title:
|
BGS649 Monotherapy in Moderate to Severe Endometriosis Patients
|
|
Scientific title:
|
A Randomized, Double-blind, Double-dummy, Placebo-controlled Study of Oral BGS649 Monotherapy Assessing Safety and Tolerability in Patients With Moderate to Severe Endometriosis |
|
Date of first enrolment:
|
July 2010 |
|
Target sample size:
|
6 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01190475 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Novartis Pharmaceuticals |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Novartis Pharmaceuticals |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Premenopausal women with documented moderate to severe endometriosis. Occurrence of
three sequential menstrual cycles of 24-35 days duration prior to enrollment.
- Laparoscopically proven diagnosis of moderate to severe endometriosis (diagnosed
within the past 10 years before screening).
- Patients not planning to become pregnant within one year after the screening visit
and willing to use two effective methods of non-hormonal, barrier birth control for
the duration of the study or who are surgically sterile.
- Patients must have a score of at least 4 on the numerical rating scale (NRS) for one
of the following three pain measurements: pelvic pain, menstrual pain and dyspareunia
Exclusion Criteria:
- Estrogen replacement therapy using either prescription medications or
estrogen-containing OTC nutritional/herbal supplements such as soy extracts or
topical estrogens.
- Aromatase inhibitor therapy (includes Femara (letrozole), Aromasin (exemestane) or
Arimidex (anastrozole) within the past 12 months.
- Oral bisphosphonate therapy (i.e. Fosamax (alendronate)) within the past 6 months or
intravenous bisphosphonate (i.e., Reclast, pamidronate) < 15 months from screening.
- Systemic glucocorticoid therapy within the past 4 weeks.
- Contra-indications to oral contraceptive use.
Other protocol-defined inclusion/exclusion criteria may apply
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Endometriosis
|
|
Intervention(s)
|
|
Drug: BGS649
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Measure: To evaluate the safety & tolerability of multiple dosing of BGS649 at two dose levels over 53 months in pre-menopausal women with moderate-severe endometriosis, as assessed by serial transvaginal ultrasonography & bone resorption biomarker
[Time Frame: 8 months. Evaluate safety and tolerability from baseline up to 3 months of treatment via transvaginal ultrasonography and up to 5 months from baseline to month 5 via bone resorption biomarker.]
|
|
Secondary Outcome(s)
|
|
Measure: To evaluate the pharmacokinetic profile of BGS649 following multiple dosing at two dose levels over 3 months in pre-menopausal women with moderate to severe endometriosis.
[Time Frame: 8 months (Assess PK profile from first dosing through end of study and compare PK on Day 1 of first dose to that of third month)]
|
|
Secondary ID(s)
|
|
CBGS649A2105
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|