A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding

This study has been completed.

Sponsor:

Collaborator:

Xanodyne Pharmaceuticals

Information provided by:

Ferring Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01280981

First received: January 19, 2011

Last updated: June 28, 2011

Last verified: June 2011

History of Changes

Results First Received: May 3, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Menorrhagia
Intervention:	Drug: Tranexamic acid

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants who completed double-blind therapy in either study XP12B-MR-301 (NCT00401193) or XP12B-MR-303 (NCT00386308) could participate in this trial.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Tranexamic Acid	Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).

Participant Flow: Overall Study

	Tranexamic Acid
STARTED	288
Intent to Treat (ITT) Population	260 ^[1]
COMPLETED	196
NOT COMPLETED	92
Withdrawal by Subject	11
Protocol Violation	2
Lack of Efficacy	13
Lost to Follow-up	3
Adverse Event	6
Irregular or discontinued menses	3
Failed to return	45
Non-compliance with protocol	3
Withdrawal of consent	3
Elective surgery	2
Study site closure	1

[1]	Participants who took drug during at least one menstrual cycle

Baseline Characteristics

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Reporting Groups

	Description
Tranexamic Acid	Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).

Baseline Measures

	Tranexamic Acid
Number of Participants [units: participants]	288
Age [units: participant]
<=18 years	0
Between 18 and 65 years	288
>=65 years	0
Gender [units: participants]
Female	288
Male	0

Outcome Measures

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1. Primary:

Participants With Treatment-Emergent Adverse Events (AEs) [ Time Frame: Day 1 to up to Month 9 ]

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2. Secondary:

Participants With Abnormal Gynecological Examinations [ Time Frame: Day 1 to up to Month 9 ]

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3. Secondary:

Mean Blood Pressure Measurements at Week 36 [ Time Frame: approximately week 36 ]

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4. Secondary:

Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment [ Time Frame: Day 1 to up to Month 9 ]

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5. Secondary:

Mean Intraocular Pressure at Month 9 [ Time Frame: Day 1 up to Month 9 ]

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6. Secondary:

Mean Fridericia-corrected QT Interval (QTcFRI) at Month 9 [ Time Frame: Month 9 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com

No publications provided

Responsible Party:	Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01280981 History of Changes
Other Study ID Numbers:	XP12B-MR-304
Study First Received:	January 19, 2011
Results First Received:	May 3, 2011
Last Updated:	June 28, 2011
Health Authority:	United States: Food and Drug Administration

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