EndometriosisPhase 2NCT00109512
Endometriosis Trial: Study of NBI-56418 in Endometriosis
A Phase 2 study testing NBI-56418 (GnRH antagonist) in people with Endometriosis, run by Abbott at 15 sites in United States.
Trial summary
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with subjects randomized to one of three treatment groups, placebo, 75 mg and 150 mg in a 1:1:1 ratio. Study drug was administered once daily for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- NBI-56418 (GnRH antagonist)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 15 sitesUnited States
- Study dates
- Apr 2005to Jun 2006
- 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 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Be female, aged 18 to 49 years, inclusive.
- Have pelvic pain and dysmenorrhea resulting in a Composite Pelvic Sign and Symptoms Score (CPSSS) of ≥ 6.
- Have had a diagnosis of endometriosis made following laparoscopic visualization of the disease within the last 5 years of the start of screening.
- Have regular menstrual cycles (28 days ±5 days) for greater than or equal to 2 years. For the cycle that immediately precedes dosing, cycle length will be determined as part of the medical history.
- Have a Body Mass Index between 18 and 30 kg/m2.
- Agree to use two forms of non-hormonal contraception (unless sterilized by tubal ligation) for greater than or equal to 3 months prior to Screening through ovulation and return of menses after treatment.
Show all 11Show fewer
- Have a negative serum pregnancy test at Screening and a negative urine pregnancy test at prior to dosing at the beginning of Week 1.
- Have a cervical smear negative for malignancy at Screening.
- Be willing to comply with all study procedures and restrictions.
- Be able to read, understand, and sign the ICF (informed consent form) before entering into the study.
- Be willing to provide authorization for access to personal health information in conjunction with US Health Insurance Portability and Accountability Act (HIPAA).
Who cannot join
- Are currently receiving a GnRH agonist or GnRH antagonist, or have received any of these agents within 6 months of Screening.
- Have been nonresponsive to GnRH agonist or antagonist therapy for the management of endometriosis.
- Are currently receiving hormonal therapy including the oral contraceptive pill or have received any of these agents within 3 months of Screening.
- Are on any concurrent medical treatment/medications or have had surgical or hormonal treatment other than oral contraceptives for endometriosis within 3 months of Screening.
- Have uterine fibroids or any other pelvic lesions greater than or equal to 3 cm in diameter as verified by ultrasound.
- Are currently breast-feeding an infant.
Show all 16Show fewer
- Are using any steroid preparation, taken by any route (e.g., oral, inhaled) on a chronic or regular basis within 3 months of Screening.
- Have an unstable medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study outcomes.
- Have chronic pelvic pain that is not caused by endometriosis.
- Have any psychological disorder according to criteria indicated in the Diagnostics and Statistical Manual of Mental Disorders, 4th edition within one year before screening. Such disorders include, but are not limited to, alcohol and substance abuse/dependence.
- Have a history of poor compliance in clinical research studies.
- Have a medically significant illness in the 30 days before the beginning of Week 1.
- Have a medically significant abnormality observed upon Screening or the beginning of Week 1 physical examination, or in any other baseline measurement. Findings outside the standard reference ranges will be jointly approved with NBI's (Neurocrine Biosciences) Medical Monitor before being considered eligible for the study.
- Are using any investigational drug within 2 months of Screening.
- Have a positive human immunodeficiency virus antibody (HIV Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV-Ab) assay at Screening or have a history of a positive result.
- Have an allergy, hypersensitivity, or intolerance to a GnRH agonist or antagonist.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Site Reference ID/Investigator# 55211
Arlington, Texas, 76012
Site Reference ID/Investigator# 56270
Champaign, Illinois, 61820
Site Reference ID/Investigator# 56273
Chicago, Illinois, 60612
Site Reference ID/Investigator# 56267
Clearwater, Florida, 33759
Site Reference ID/Investigator# 56272
Louisville, Kentucky, 40291
Site Reference ID/Investigator# 56269
Oak Brook, Illinois, 60523
Site Reference ID/Investigator# 56271
Peoria, Illinois, 61615
Site Reference ID/Investigator# 56266
Phoenix, Arizona, 85032
Site Reference ID/Investigator# 56274
Richmond, Virginia, 23294
Site Reference ID/Investigator# 55210
San Diego, California, 92103
Site Reference ID/Investigator# 55214
San Ramon, California, 94566
Site Reference ID/Investigator# 56268
Sandy City, Utah, 84070
Site Reference ID/Investigator# 56275
Spokane, Washington, 99204
Site Reference ID/Investigator# 55212
Virginia Beach, Virginia, 23451
Site Reference ID/Investigator# 55213
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of NBI-56418 in Endometriosis
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with subjects randomized to one of three treatment groups, placebo, 75 mg and 150 mg in a 1:1:1 ratio. Study drug was administered once daily for 12 weeks. After the last dose at the end of Week 12, follow-up continued every 4 weeks for 12 weeks.
- Conditions
- Endometriosis
- Being tested
- NBI-56418 (GnRH antagonist), placebo
- Keywords
- endometriosis, pelvic pain, painful periods, dysmenorrhea, painful menstruation, GnRH, agonist, antagonist, menstrual pain
- Medical subject headings
- Endometriosis, Pelvic Pain, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI-56418 (GnRH antagonist)Drug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| NBI-56418 75 mg | Experimental | Not described Receives: Drug: NBI-56418 (GnRH antagonist) |
| NBI-56418 150 mg | Experimental | Not described Receives: Drug: NBI-56418 (GnRH antagonist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Composite Pelvic Signs and Symptom Scale (CPSSS) scores
This scale is used to assess the signs (pelvic tenderness and induration) and symptoms (nonmenstrual pelvic pain, dysmenorrhea and dyspareunia) associated with endometriosis.
Measured: Every 4 weeks
Secondary outcomes (7)
Endometriosis Health Profile-5 (EHP-5)
The EHP-5 assesses quality of life.
Measured: Every 4 weeks
Visual Analog Scale (VAS) scores
VAS measures endometriosis pain.
Measured: Every 4 weeks
Number of Subjects with Adverse Events
Measured: Up to 24 weeks
Clinical Laboratory Tests
Measured: Up to 24 weeks
Vital Sign Measurements
Measured: Up to 24 weeks
Physical Examinations
Measured: Up to 24 weeks
Electrocardiogram (ECG) tracings
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2005 (estimated)
- Study startApr 2005
- Primary completionJun 2006
- Study completionJun 2006
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Laura Williams, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109512
- Sponsor's protocol ID
- NBI-56418-0501
- Status last verified
- Feb 2012
- First submitted
- 28 Apr 2005
- Last updated
- 22 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of NBI-56418 in Endometriosis
- ClinicalTrials.gov ID
- NCT00109512
- Acronym / sponsor ID
- NBI-56418-0501
- Conditions
- Endometriosis
- Keywords
- endometriosis, pelvic pain, painful periods, dysmenorrhea, painful menstruation, GnRH, agonist, antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 29 Apr 2005 (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.
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with subjects randomized to one of three treatment groups, placebo, 75 mg and 150 mg in a 1:1:1 ratio. Study drug was administered once daily for 12 weeks. After the last dose at the end of Week 12, follow-up continued every 4 weeks for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| NBI-56418 75 mg | Experimental | Drug: NBI-56418 (GnRH antagonist) |
| NBI-56418 150 mg | Experimental | Drug: NBI-56418 (GnRH antagonist) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Be female, aged 18 to 49 years, inclusive.
- Have pelvic pain and dysmenorrhea resulting in a Composite Pelvic Sign and Symptoms Score (CPSSS) of ≥ 6.
- Have had a diagnosis of endometriosis made following laparoscopic visualization of the disease within the last 5 years of the start of screening.
- Have regular menstrual cycles (28 days ±5 days) for greater than or equal to 2 years. For the cycle that immediately precedes dosing, cycle length will be determined as part of the medical history.
- Have a Body Mass Index between 18 and 30 kg/m2.
Key exclusion criteria (16 listed)
- Are currently receiving a GnRH agonist or GnRH antagonist, or have received any of these agents within 6 months of Screening.
- Have been nonresponsive to GnRH agonist or antagonist therapy for the management of endometriosis.
- Are currently receiving hormonal therapy including the oral contraceptive pill or have received any of these agents within 3 months of Screening.
- Are on any concurrent medical treatment/medications or have had surgical or hormonal treatment other than oral contraceptives for endometriosis within 3 months of Screening.
- Have uterine fibroids or any other pelvic lesions greater than or equal to 3 cm in diameter as verified by ultrasound.
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 |
|---|---|---|
| NBI-56418 (GnRH antagonist) | Drug | NBI-56418 150 mg, NBI-56418 75 mg |
| placebo | Drug | placebo |
Primary outcome
Total Composite Pelvic Signs and Symptom Scale (CPSSS) scores
Time frame: Every 4 weeks
This scale is used to assess the signs (pelvic tenderness and induration) and symptoms (nonmenstrual pelvic pain, dysmenorrhea and dyspareunia) associated with endometriosis.
7 secondary outcomes
Endometriosis Health Profile-5 (EHP-5)
Time frame: Every 4 weeks
Visual Analog Scale (VAS) scores
Time frame: Every 4 weeks
Number of Subjects with Adverse Events
Time frame: Up to 24 weeks
Clinical Laboratory Tests
Time frame: Up to 24 weeks
Vital Sign Measurements
Time frame: Up to 24 weeks
Physical Examinations
Time frame: Up to 24 weeks
Electrocardiogram (ECG) tracings
Time frame: Up to 24 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 22 Feb 2012.
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Laura Williams, MD study director
Abbott
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NBI-56418 (GnRH antagonist) in people with Endometriosis, run by Abbott at 15 sites in United States.
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 11 inclusion and 16 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 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Total Composite Pelvic Signs and Symptom Scale (CPSSS) scores (time frame: Every 4 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 22 Feb 2012.