Safety Study of XP12B in Women With Menorrhagia

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Multicenter Study to Evaluate the Safety of XP12B in Women With Heavy Menstrual Bleeding Associated With Menorrhagia

ClinicalTrials.gov ID

NCT00113568

Acronym / sponsor ID

XP12B-MR-302

Conditions

Menorrhagia, Heavy Menstrual Bleeding

Keywords

Menorrhagia, Heavy Menstrual Bleeding

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

784 participants (actual)

Lead sponsor

Ferring PharmaceuticalsIndustry (pharma, biotech, devices)

Study start

Jun 2005

Primary completion

May 2009 (actual)

Study completion

May 2009 (actual)

First posted

9 Jun 2005 (estimated)

Results

Posted 20 Jan 2010

Clinical summary

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

Study design

Primary purpose

Treatment

Allocation

Non-randomised

Intervention model

Single group

Masking

None (open label)

Number of arms

1

Who may qualify

Ages

18 to 49 years

Sex

Female only

Healthy volunteers

Not accepted

Age groups

Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Subjects With at Least One Adverse Event During the Study

   Time frame: Up to 27 menstrual cycles

   An adverse event is any untoward, undesired, unplanned clinical event in the form of signs. symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study with a sponsor study drug, regardless of causal relationship.

2. Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study

   Time frame: Up to 27 menstrual cycles

   The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A possibly treatment-related adverse event is an event that may be explained by administration of the study drug or by the subjects's clinical state or other agents/therapies.

3. Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study

   Time frame: Up to 27 menstrual cycles

   The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A probably treatment-related adverse event is an event most likely to be explained by administration of the study drug rather than the subjects's clinical state or other agents/therapies.

4. Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study

   Time frame: Up to 27 menstrual cycles

   The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A definitely treatment-related adverse event is an event that can be fully explained by administration of the study drug.

5. Number of Subjects With at Least One Serious Adverse Event During the Study

   Time frame: Up to 27 menstrual cycles

   A serious adverse event (SAE) is any adverse event (AE) occurring at any dose that meets 1 or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in a persistent or significant disability or incapacity; results in cancer; results in a congenital anomaly or birth defect. Important medical events not described above may be considered SAEs when based on appropriate medical judgment.

6. Number of Subjects With at Least One Life-Threatening Adverse Event During the Study

   Time frame: Up to 27 menstrual cycles

   A life-threatening AE is any AE that places the subject at immediate risk of death from the event as it occurred.

7. Number of Subjects With Adverse Events That Led to Discontinuation From the Study

   Time frame: Up to 27 menstrual cycles

   The total number of subjects who withdrew from the study due to an adverse event irrespective of the causal relation between the AE and the study drug as determined by the investigator

8. Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study

   Time frame: Up to 27 menstrual cycles

   Examples include deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, central retinal artery and vein obstruction.

9. Number of Subjects Who Died During the Study

   Time frame: Up to 27 menstrual cycles

   Number of subjects who died, for any reason, during the study

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2010.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 21867401Muse K, Lukes AS, Gersten J, Waldbaum A, Mabey RG, Trott E. Long-term evaluation of safety and health-related quality of life in women with heavy menstrual bleeding treated with oral tranexamic acid. Womens Health (Lond). 2011 Nov;7(6):699-707. doi: 10.2217/whe.11.65. Epub 2011 Aug 25.
• Derived from this study: PubMed 21043553Bushnell DM, Martin ML, Moore KA, Richter HE, Rubin A, Patrick DL. Menorrhagia Impact Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life. Curr Med Res Opin. 2010 Dec;26(12):2745-55. doi: 10.1185/03007995.2010.532200. Epub 2010 Nov 3.

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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.

59 sites in 1 country: see every site and its status.