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Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding

NCT01391052 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-07-11

No results posted yet for this study

Summary

Problematic uterine bleeding after the insertion of the LNG IUS is a well documented side effect. The levonorgestrel intrauterine system (LNG IUS) was approved for treatment of heavy menstrual bleeding (HMB) by the FDA in October 2009. To reduce the incidence and severity of post-insertional uterine bleeding, pretreatment with norethindrone acetate may effectively slough the endometrium prior to insertion of the LNG IUS.

Conditions

  • Heavy Menstrual Bleeding
  • Menorrhagia
  • Hypermenorrhea

Interventions

DRUG

Norethindrone acetate pretreatment

5 mg tablets, three times a day for 21 days for 2 menstrual cycles.

OTHER

No pretreatment

LVN IUS is placed withour Norethindrone acetate pretreatment.

Sponsors & Collaborators

  • Scott and White Hospital & Clinic

    lead OTHER

Principal Investigators

  • Patricia J Sulak, MD · Scott and White Hospital & Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01391052 on ClinicalTrials.gov