EndometriosisPhase 2NCT01629420
A Phase II Randomized Open Label Study of KLH-2109 in Patients With Endometriosis
A Phase 2 study testing KLH-2109 in people with Endometriosis, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- KLH-2109
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with endometriosis
Who cannot join
- Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Open Label Phase II Study of KLH-2109 in Patients With Endometriosis(3)
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.
- Conditions
- Endometriosis
- Being tested
- KLH-2109
- Keywords
- Gonadotropin-Releasing Hormone (GnRH) antagonist
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLH-2109Drug
KLH-2109Drug
| Study group | Role | What they receive |
|---|---|---|
| Drug:KLH-2109 lower dose | Experimental | Not described Receives: Drug: KLH-2109 |
| Drug:KLH-2109 higher dose | Experimental | Not described Receives: Drug: KLH-2109 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity score of the pelvic pain
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629420
- Sponsor's protocol ID
- KLH1203
- Status last verified
- May 2014
- First submitted
- 25 Jun 2012
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open Label Phase II Study of KLH-2109 in Patients With Endometriosis(3)
- ClinicalTrials.gov ID
- NCT01629420
- Acronym / sponsor ID
- KLH1203
- Conditions
- Endometriosis
- Keywords
- Gonadotropin-Releasing Hormone (GnRH) antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 27 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug:KLH-2109 lower dose | Experimental | Drug: KLH-2109 |
| Drug:KLH-2109 higher dose | Experimental | Drug: KLH-2109 |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients with endometriosis
Key exclusion criteria (1 listed)
- Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KLH-2109 | Drug | Drug:KLH-2109 lower dose |
| KLH-2109 | Drug | Drug:KLH-2109 higher dose |
Primary outcome
The severity score of the pelvic pain
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KLH-2109 in people with Endometriosis, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity score of the pelvic pain (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2014.