AdenomyosisPhase 2NCT02794467
Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis
A Phase 2 study testing Epelsiban in people with Adenomyosis, run by GlaxoSmithKline at 13 sites in United States.
Trial summary
The primary objective of the study is to assess the efficacy, safety, and tolerability of epelsiban compared with placebo in treatment of women with adenomyosis. This is a 12-week, randomized, double-blind, placebo-controlled, parallel group study with an interim futility analysis. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Adenomyosis
- What is being tested?
- Epelsiban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 13 sitesUnited States
- Study dates
- Jul 2016to Oct 2016
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Eighteen to 55 years of age, inclusive
- Pre-menopausal with a history of regular menstrual cycles every 21-35 days and without intermenstrual bleeding heavier than spotting and staining.
- Females with adenomyosis confirmed on magnetic resonance imaging (MRI), - Females with heavy menstrual bleeding .
- Willing and able to collect all menstrual cycle by-products for each cycle from screening to follow up.
- Not pregnant as confirmed by a negative serum human chorionic gonadotropin
Who cannot join
- A female subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Abnormal gynecological examination other than adenomyosis and/or breast examination requiring intervention within six months of study start
- Abnormal endometrial biopsy within six months of starting study treatment.
- History of an endometrial ablation within 12 months of starting study treatment.
- Uterine artery embolization within six months of starting study treatment.
- Prior major uterine procedures or any other significant uterine abnormalities on MRI (previous caesarean section, dilation and curettage, and diagnostic hysteroscopy are permitted).
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- Confirmed rectovaginal endometriosis in women who have undergone a prior laparoscopy.
- Active pelvic infection or current use of an intrauterine device within three months of screening.
- Women with a history of transfusion for heavy menstrual bleeding within the past 2 years or history of postpartum hemorrhage.
- Any uterine dimension >20 centimeter (cm).
- Other major causes of heavy menstrual bleeding -
- Use within 3 months or anticipated use of medications that modify reproductive function
- Use or anticipated use of the following drugs: anticoagulants aminocaproic acid ,or any other medications that affect menstrual bleeding such as tranexamic acid.
- Use of daily opioid pain medications other than with menses.
- Hemoglobin <8 grams (g)/deciliter.
- History of bleeding disorder or known presence of acquired or inherited thrombophilia, (sickle cell trait individuals are not excluded).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
GSK Investigational Site
Champaign, Illinois, 61820
GSK Investigational Site
Durham, North Carolina, 27713
GSK Investigational Site
Englewood, Ohio, 45322
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Las Vegas, Nevada, 89128
GSK Investigational Site
Lawrenceville, New Jersey, 08648
GSK Investigational Site
Lincoln, Nebraska, 68510
GSK Investigational Site
Mandeville, Louisiana, 70471
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Pittsburgh, Pennsylvania, 15206
GSK Investigational Site
Raleigh, North Carolina, 27612
GSK Investigational Site
Washington D.C., District of Columbia, 20036
GSK Investigational Site
West Palm Beach, Florida, 33409
About this study
Official title: A Phase II, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Proof of Concept Study With an Interim Futility Analysis of Epelsiban in Patients With Adenomyosis
The primary objective of the study is to assess the efficacy, safety, and tolerability of epelsiban compared with placebo in treatment of women with adenomyosis.
This is a 12-week, randomized, double-blind, placebo-controlled, parallel group study with an interim futility analysis. Subjects will be randomized 1:1:1 to receive 75 milligrams (mg) of epelsiban three times daily (TID), 200 mg of epelsiban TID, or placebo TID. The study will be composed of three periods: screening, treatment, and follow-up and the total time a subject will be in the study will be approximately 6 months.
- Conditions
- Adenomyosis
- Being tested
- Epelsiban, Placebo
- Keywords
- Heavy menstrual bleeding, Adenomyosis, Safety, Epelsiban, Tolerability, Proof of concept
- Medical subject headings
- Adenomyosis, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpelsibanDrug
Epelsiban will be supplied as modified capsule shaped, white coated, oral tablet with a unit dose strength of 25 or 150 mg; to be taken with food or immediately after a meal, without chewing
PlaceboDrug
A matching placebo will be supplied as modified capsule shaped, white coated, oral tablet; to be taken with food or immediately after a meal, without chewing.
| Study group | Role | What they receive |
|---|---|---|
| Epelsiban 75 mg | Experimental | Approximately 24 subjects will receive 75 mg of epelsiban three times a day (TID) via oral administration Receives: Drug: Epelsiban |
| Epelsiban 200 mg | Experimental | Approximately 24 subjects will receive 200 mg of epelsiban TID via oral administration Receives: Drug: Epelsiban |
| Placebo | Placebo comparator | Approximately 24 subjects will receive a matching placebo TID via oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change from baseline in monthly menstrual blood loss (MBL) to menstrual Cycle 3
MBL will be measured from blood collected from menstrual cycle by-products and recovered by alkaline hematin method during each menstrual cycle
Measured: Baseline and end of menses Cycle 3 (approximately 12 weeks)
Number of subjects with adverse events (AE)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; safety and tolerability as assessed by incidence of adverse events
Measured: Up to 3 months
Secondary outcomes (2)
Change from baseline in monthly menstrual blood loss (MBL) at menstrual Cycle 1, 2, and 3
MBL will be measured from blood collected from menstrual cycle by-products
Measured: Baseline, and end of menses Cycle 1, 2, and 3 (approximately 12 weeks)
Average daily dysmenorrhea score from Day -1 to Day 2 in each cycle
Average daily dysmenorrhea score from Day -1 to Day 2 of menses
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2016
- Study completionOct 2016 (estimated)
Why it stopped: Study was prematurely discontinued due to GSK's change in prioritization for the portfolio and is not due to any safety concerns or regulatory interaction.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794467
- Sponsor's protocol ID
- 201580
- Status last verified
- Jan 2017
- First submitted
- 6 Jun 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Proof of Concept Study With an Interim Futility Analysis of Epelsiban in Patients With Adenomyosis
- ClinicalTrials.gov ID
- NCT02794467
- Acronym / sponsor ID
- 201580
- Conditions
- Adenomyosis
- Keywords
- Heavy menstrual bleeding, Adenomyosis, Safety, Epelsiban, Tolerability, Proof of concept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was prematurely discontinued due to GSK's change in prioritization for the portfolio and is not due to any safety concerns or regulatory interaction.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 9 Jun 2016 (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 primary objective of the study is to assess the efficacy, safety, and tolerability of epelsiban compared with placebo in treatment of women with adenomyosis.
This is a 12-week, randomized, double-blind, placebo-controlled, parallel group study with an interim futility analysis. Subjects will be randomized 1:1:1 to receive 75 milligrams (mg) of epelsiban three times daily (TID), 200 mg of epelsiban TID, or placebo TID. The study will be composed of three periods: screening, treatment, and follow-up and the total time a subject will be in the study will be approximately 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epelsiban 75 mg | Experimental | Drug: EpelsibanApproximately 24 subjects will receive 75 mg of epelsiban three times a day (TID) via oral administration |
| Epelsiban 200 mg | Experimental | Drug: EpelsibanApproximately 24 subjects will receive 200 mg of epelsiban TID via oral administration |
| Placebo | Placebo comparator | Drug: PlaceboApproximately 24 subjects will receive a matching placebo TID via oral administration |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Eighteen to 55 years of age, inclusive
- Pre-menopausal with a history of regular menstrual cycles every 21-35 days and without intermenstrual bleeding heavier than spotting and staining.
- Females with adenomyosis confirmed on magnetic resonance imaging (MRI), - Females with heavy menstrual bleeding .
- Willing and able to collect all menstrual cycle by-products for each cycle from screening to follow up.
- Not pregnant as confirmed by a negative serum human chorionic gonadotropin
Key exclusion criteria (16 listed)
- A female subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Abnormal gynecological examination other than adenomyosis and/or breast examination requiring intervention within six months of study start
- Abnormal endometrial biopsy within six months of starting study treatment.
- History of an endometrial ablation within 12 months of starting study treatment.
- Uterine artery embolization within six months of starting study treatment.
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 |
|---|---|---|
| EpelsibanEpelsiban will be supplied as modified capsule shaped, white coated, oral tablet with a unit dose strength of 25 or 150 mg; to be taken with food or immediately after a meal, without chewing | Drug | Epelsiban 200 mg, Epelsiban 75 mg |
| PlaceboA matching placebo will be supplied as modified capsule shaped, white coated, oral tablet; to be taken with food or immediately after a meal, without chewing. | Drug | Placebo |
Primary outcome
Mean percent change from baseline in monthly menstrual blood loss (MBL) to menstrual Cycle 3
Time frame: Baseline and end of menses Cycle 3 (approximately 12 weeks)
MBL will be measured from blood collected from menstrual cycle by-products and recovered by alkaline hematin method during each menstrual cycle
Number of subjects with adverse events (AE)
Time frame: Up to 3 months
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; safety and tolerability as assessed by incidence of adverse events
2 secondary outcomes
Change from baseline in monthly menstrual blood loss (MBL) at menstrual Cycle 1, 2, and 3
Time frame: Baseline, and end of menses Cycle 1, 2, and 3 (approximately 12 weeks)
Average daily dysmenorrhea score from Day -1 to Day 2 in each cycle
Time frame: Up to 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
13 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 Epelsiban in people with Adenomyosis, run by GlaxoSmithKline at 13 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 5 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: withdrawn, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 was withdrawn before enrolling participants, so there are no results.
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?
Mean percent change from baseline in monthly menstrual blood loss (MBL) to menstrual Cycle 3 (time frame: Baseline and end of menses Cycle 3 (approximately 12 weeks)). The study lists 2 primary outcomes in all. 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 18 Jan 2017.