EndometriosisPhase 2NCT01190475

BGS649 Monotherapy in Moderate to Severe Endometriosis Patients

A Phase 2 study testing Active treatment with a high dose of BGS649 and Active treatment with a low dose of BGS649 in people with Endometriosis, run by Mereo BioPharma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis. Read more about this study

Who is it for?: Ages 18 to 40 years, women only
Conditions the study is for: Endometriosis
What is being tested?: Active treatment with a high dose of BGS649 and Active treatment with a low dose of BGS649
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Jul 2010to Sep 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Novartis Investigative Site
Anaheim, California, 92801

Other trials in United States

About this study

Official 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

This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.

Conditions: Endometriosis
Being tested: Active treatment with a high dose of BGS649, Active treatment with a low dose of BGS649, Placebo treatment to blind study
Keywords: Endometriosis, Infertility, Pain, Vaginal Diseases, Uterine Diseases
Medical subject headings: Endometriosis, Infertility, Pain, Vaginal Diseases, Uterine Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active treatment with a high dose of BGS649Drug
Active treatment with a low dose of BGS649Drug
Placebo treatment to blind studyDrug

Study groups in NCT01190475
Study group	Role	What they receive
BGS649 high dose	Experimental	1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules. Receives: Drug: Active treatment with a high dose of BGS649
BGS649 low dose	Experimental	1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules Receives: Drug: Active treatment with a low dose of BGS649
Placebo to BGS649	Placebo comparator	1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules Receives: Drug: Placebo treatment to blind study

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger
Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.
Measured: 8 months

Secondary outcomes (3)

Pharmacokinetic Profille of BGS649 as Described by AUC0-672h
AUC0-672 is a measurement of how much drug reaches a person's bloodstream in a given period of time after a dose is given. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose.
Measured: 8 hours
Pharmacokinetic Profile of BGS649 as Described by Cmax
The peak plasma concentration of BGS649 after dosing at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose.
Measured: 8 hours
Pharmacokinetic Profile of BGS649 as Described by Tmax
Time taken to reach the maximum concentration in plasma of BGS649 at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occurred at pre-dose, 0.5-1.5h and 4-8 h post-dose.
Measured: 8 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Sep 2011

First posted27 Aug 2010 (estimated)
Study startJul 2010
Primary completionSep 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01190475
Sponsor's protocol ID: CBGS649A2105
Status last verified: Oct 2020
First submitted: 19 Aug 2010
Last updated: 27 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Endometriosis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT01190475
Acronym / sponsor ID: CBGS649A2105
Conditions: Endometriosis
Keywords: Endometriosis, Infertility, Pain, Vaginal Diseases, Uterine Diseases
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Mereo BioPharmaIndustry (pharma, biotech, devices)
Collaborators: Novartis
Study start: Jul 2010
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 27 Aug 2010 (estimated)
Results: Posted 14 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.

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
BGS649 high dose	Experimental	Drug: Active treatment with a high dose of BGS6491 BGS649 1.0mg capsule with three 0.1 mg placebo capsules.
BGS649 low dose	Experimental	Drug: Active treatment with a low dose of BGS6491 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules
Placebo to BGS649	Placebo comparator	Drug: Placebo treatment to blind study1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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.

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
Active treatment with a high dose of BGS649	Drug	BGS649 high dose
Active treatment with a low dose of BGS649	Drug	BGS649 low dose
Placebo treatment to blind study	Drug	Placebo to BGS649

Primary outcome

Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger
Time frame: 8 months
Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.

3 secondary outcomes

Pharmacokinetic Profille of BGS649 as Described by AUC0-672h
Time frame: 8 hours
Pharmacokinetic Profile of BGS649 as Described by Cmax
Time frame: 8 hours
Pharmacokinetic Profile of BGS649 as Described by Tmax
Time frame: 8 hours

Results and safety

Results posted to the registry on 14 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BGS649 High Dose	2	2
BGS649 Low Dose	2	2
Placebo	2	1

Primary outcome: Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger

Time frame: 8 months. Count of participants. Unit: Participants

Measure	BGS649 High Dose n = 2	BGS649 Low Dose n = 2	Placebo n = 2
Value	2	2	0

Population analysed: Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BGS649 High Dose	0 of 2 (0%)	2 of 2 (100%)	Not reported
BGS649 Low Dose	0 of 2 (0%)	2 of 2 (100%)	Not reported
Placebo	0 of 2 (0%)	2 of 2 (100%)	Not reported

Limitations and caveats (from the sponsor): The study was prematurely terminated because the safety endpoint was reached after a total of 6 patients were randomized into one of the 3 treatment arms.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Endometriosis

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Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
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Recruiting
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Not yet recruiting
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Not yet recruitingObservational study
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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.

Jacqueline Parkin, PhD FRCP study director

Mereo BioPharma

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 Active treatment with a high dose of BGS649 and Active treatment with a low dose of BGS649 in people with Endometriosis, run by Mereo BioPharma at 1 site 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 4 inclusion and 6 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 27 Oct 2020. 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 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?

Yes. Results are posted in the registry (first posted 14 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger (time frame: 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01190475.

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 27 Oct 2020.