A Randomized Open Label Study of KLH-2109 in Patients With Endometriosis(1)
Sponsor
Kissei Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01395940
Collaborator
(none)
20
1
2
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Open Label Phase II Study of KLH-2109 in Patients With Endometriosis(1)
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: KLH-2109, lower dose
|
Drug: KLH-2109
|
| Experimental: KLH-2109, higher dose
|
Drug: KLH-2109
|
Outcome Measures
Primary Outcome Measures
- The severity score of the pelvic pain [8 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Female patients with endometriosis
Exclusion Criteria:
- Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Japan | Tokyo and Other Japanese City | Japan |
Sponsors and Collaborators
- Kissei Pharmaceutical Co., Ltd.
Investigators
- Study Director: Katsumi Hontani, Kissei Pharmaceutical Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01395940
Other Study ID Numbers:
- KLH1201
First Posted:
Jul 18, 2011
Last Update Posted:
Oct 30, 2013
Last Verified:
Oct 1, 2013
Keywords provided by ,
,
Additional relevant MeSH terms: