Minimize Menorrhagia in Women With Von Willebrand Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 8 July 2024
• Main ID: NCT02606045
• Date of registration: 05/11/2015
• Prospective Registration: Yes
• Primary sponsor: Margaret Ragni
• Public title: Minimize Menorrhagia in Women With Von Willebrand Disease VWDMin
• Scientific title: Prospective, Randomized, Crossover Trial Comparing Recombinant Von Willebrand Factor (rVWF) vs. Tranexamic Acid (TA) to Minimize Menorrhagia in Women With Von Willebrand Disease: The VWD Minimize Study
• Date of first enrolment: February 7, 2019
• Target sample size: 39
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT02606045
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Margaret V Ragni, MD, MPH
• Affiliation: University of Pittsburgh

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Adult females 13-45 years of age.

2. Mild or moderate von Willebrand disease (VWF:RCo <0.50 IU/ml, normal multimers, past
bleeding)

3. Menorrhagia defined as PBAC >100 in at least one of the last two menstrual cycles.

4. Regular menses, at least every 21-35 days.

5. Willingness to have blood drawn

6. No prior history of an allergic reaction or anaphylaxis to rVWF or TA.

7. Willingness to avoid aspirin (ASA) and nonsteroidal anti-inflammatory agents
(NSAIDS) during the study.

8. Willingness to comply with randomization to rVWF or TA study arms.

9. Willingness to keep a personal diary of menorrhagia bleeding frequency duration and
severity by pictorial blood assessment chart, and any drugs or hemostatic agents
taken.

10. Willingness to make 4 visits and undergo blood sampling for coagulation studies, and
accept randomization of two therapies for each of four consecutive menstrual cycles,
including an end-of-study visit.

11. Willingness to use "double-barrier" method of contraception during the study.

Exclusion Criteria:

1. Any bleeding disorder other than von Willebrand disease; or past thrombotic disease

2. Pregnant or lactating, or use of hormones (other than progesterone-only), or
combined oral contraceptives, and contraceptive implants in past 3 months.

3. Platelet count < 100,000/ul.

4. Use of immunomodulatory or experimental drugs.

5. Surgery within the past 8 weeks.

6. Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs.

7. Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives
containing VWF within 5 days of study.

8. Inability to comply with study requirements.

9. Hypothyroidism as defined by elevated TSH.

10. Iron deficiency as defined by low serum ferritin, unless iron replacement has been
initiated.

11. History of renal disease


Age minimum: 13 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Von Willebrand Diseases

Intervention(s)

Drug: recombinant von Willebrand factor

Drug: tranexamic acid

Primary Outcome(s)

Menstrual Bleeding Severity [Time Frame: 4 weeks.]

Secondary Outcome(s)

Center for Epidemiology Studies Depression Scale (CES-D) [Time Frame: 4 weeks.]

Rand Short Form 36-Question Health Survey (SF-36) [Time Frame: 4 weeks]

Ruta Menorrhagia Severity Scale [Time Frame: 4 weeks.]

Cycle Duration [Time Frame: 4 weeks.]

Center for Disease Control Health-Related Quality of Life 14 Questions (CDC-HRQoL-14) [Time Frame: 4 weeks.]

Cycle Severity [Time Frame: 4 weeks]

Secondary ID(s)

U01HL133815

STUDY19030221

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)

University of North Carolina

Duke University

Results

• Results available: Yes
• Date Posted: 01/07/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02606045