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Trial record 90 of 404 for:    LEVONORGESTREL

Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)

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ClinicalTrials.gov Identifier: NCT02824224
Recruitment Status : Completed
First Posted : July 6, 2016
Results First Posted : May 21, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Jensen, Oregon Health and Science University

Brief Summary:
This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in new users of the 52mg levonorgestrel-releasing intrauterine device (IUD). Half of participants will receive a course of tamoxifen three weeks after insertion of the IUD, while the other half of participants will receive a course of placebo.

Condition or disease Intervention/treatment Phase
Menorrhagia Metrorrhagia Medicated Intrauterine Devices Drug: Tamoxifen Drug: Placebo (for Tamoxifen) Phase 4

Detailed Description:
New users of the LNG IUD will be eligible. Subjects will be randomized to receive tamoxifen 10 mg twice daily for 7 days or placebo. Study drug will be started 3 weeks after placement of the IUD. Subjects will maintain a record of daily bleeding and spotting using an electronic text messaging diary.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
Actual Study Start Date : September 6, 2016
Actual Primary Completion Date : January 8, 2018
Actual Study Completion Date : January 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Tamoxifen
Tamoxifen 10mg tablet by mouth twice daily for 7 days
Drug: Tamoxifen
10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course
Other Name: Nolvadex

Placebo Comparator: Placebo
Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days
Drug: Placebo (for Tamoxifen)
Sugar pill manufactured to mimic the tamoxifen 10mg tablet




Primary Outcome Measures :
  1. Number of Bleeding and Spotting Days [ Time Frame: 30 days after initiation of study drug ]
    Mean number of bleeding and spotting days in the tamoxifen group compared to the mean number of bleeding and spotting days in the placebo group


Secondary Outcome Measures :
  1. Bleeding Pattern Satisfaction [ Time Frame: 30 days after initiation of study drug ]
    0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with bleeding pattern. 0 mm = not at all satisfied, 100 mm = very satisfied.

  2. IUD Satisfaction [ Time Frame: 30 days after initiation of study drug ]
    0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with IUD (intrauterine device). 0 mm = not at all satisfied, 100 mm = very satisfied.

  3. Adverse Events [ Time Frame: 30 days after initiation of study drug ]
    Descriptive reporting of adverse events for each arm


Other Outcome Measures:
  1. Total Number of Bleeding/Spotting Episodes [ Time Frame: 60 days after initiation of study drug ]
  2. Number of Prolonged Bleeding Episodes (>8 Days) [ Time Frame: 60 days after initiation of study drug ]
  3. Longest Bleed-free Interval [ Time Frame: 60 days after initiation of study drug ]


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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • initiating use of 52mg levonorgestrel-releasing IUD for contraceptive purposes
  • access to reliable cell phone
  • willing to receive and respond to daily text or email message to assess bleeding

Exclusion Criteria:

  • using IUD for indication other than contraception
  • postpartum within 6 months, pregnant, or breastfeeding
  • removal and replacement of IUD
  • undiagnosed abnormal uterine bleeding prior to placement of IUD
  • bleeding dyscrasia
  • anti-coagulation use
  • active cervicitis
  • allergy to tamoxifen
  • history of venous thromboembolism
  • personal history of breast or uterine malignancy
  • use of medication contraindicated with use of tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824224


Locations
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United States, Oregon
OHSU Center For Women's Health
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Study Director: Megan A Cohen, MD, MPH Oregon Health and Science University
  Study Documents (Full-Text)

Documents provided by Jeffrey Jensen, Oregon Health and Science University:

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Responsible Party: Jeffrey Jensen, Leon Speroff Professor of Obstetrics & Gynecology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02824224     History of Changes
Other Study ID Numbers: STUDY00015881
First Posted: July 6, 2016    Key Record Dates
Results First Posted: May 21, 2019
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jeffrey Jensen, Oregon Health and Science University:
levonorgestrel
breakthrough bleeding
Additional relevant MeSH terms:
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Levonorgestrel
Menorrhagia
Metrorrhagia
Hemorrhage
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral