Recruiting

Estradiol vs. Lysteda

Sponsor:

Kay I Waud MD PhD

Code:

NCT01659008

Conditions

Menstrual Cycle and Uterine Bleeding Disorders

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Estradiol

Lysteda

Study Details

Brief summary:

Treatment with Estradiol is non-inferior to treatment with Tranexamic acid in reducing the amount and duration of menstrual blood loss in women with cyclic heavy menstrual bleeding

Conditions

Menstrual Cycle and Uterine Bleeding Disorders

Study ID

NCT01659008

Start date

Jun, 2012

Status verified date

Feb, 2015

Completion date

Mar, 2016

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age: between 18-45 years old
  • Hemoglobin concentration: less than or equal to 11.5 g/dL, greater than or equal to 8.0 g/dL
  • BMI: less than or equal to 35
  • Menstrual cycle: previous menstrual cycle interval between 26 to 34 days with less than or equal to 10 days of bleeding
  • Contraception: at least two months from implant removal, or six months from their last depo-provera or depo-Lupron injection, or recently(at least 2 months) discontinued oral, patch or intravaginal ring contraceptives
  • On cycle day 1-3 of the current menstrual bleeding episode

Exclusion Criteria:

  • NSAID, or aspirin containing medications during the 48 hours preceding the current ER visit
  • Estrogen or progestin treatment during the 30 days preceding the current ER visit
  • Using Paraguard
  • Pregnant and or lactating
  • History of endometrial ablation
  • Women with thromboembolic disease, or coagulopathy
  • Women with history of myocardial infarction, or cerebrovascular occlusion
  • Uncontrolled high blood pressure (blood pressure greater than 150/90)
  • Sensitivity to estrogen, or tranexamic acid

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: estradiol

estradiol PO 0.5mg 2 tabs three times a day for 2 days

experimental: Lysteda

Lysteda 650mg PO 2 tabs three times a day for 2 days

Interventions

Estradiol

Lysteda

Primary outcome measure

  • menstrual blood loss [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

Kay I Waud, MD PhD

3103820090waudk@evms.edu

David F Archer, MD

7574467444archerdf@evms.edu

Locations

Jones Institue Clinical Research Center

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

David F Archer, MD

757-446-7444archerdf@evms.edu

Kay I Waud, MD PhD

3103820090waduk@evms.edu

Principal Investigator:

Kay I Waud, MD PhD

Sentara Norfolk General Emergency Department

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Micheal Bono, MD

757-388-4000m.bono@charter.net

More Information

Sponsor

Kay I Waud MD PhD

Last update posted

Feb 16, 2015

Last verified

Feb, 2015

Keywords

  • acute cyclical heavy menstrual bleeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Kay I Waud MD PhD on 2015-02-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.