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

NCT01391052 | Unknown Phase 4

• 1 other identifier: 90378
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intrauterine system; reproductive age; menstrual bleeding

Outcome Measures

Primary Outcomes (1)

• Total number of bleeding days

  Number of days on study calendars with menstrual flow

  up to 180 days

Secondary Outcomes (1)

• Menorrhagia Questionnaire

  up to 180 days

Study Arms (2)

Norethindrone acetate pretreatment

ACTIVE COMPARATOR

This arm will receive two cycles of norethindrone acetate before LVN IUS insertion.

Drug: Norethindrone acetate pretreatment

No pretreatment

OTHER

LVN IUS is placed without norethindrone acetate pretreatment.

Other: No pretreatment

Interventions

Norethindrone acetate pretreatment DRUG

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

Also known as: Aygestin

Norethindrone acetate pretreatment

No pretreatment OTHER

LVN IUS is placed withour Norethindrone acetate pretreatment.

No pretreatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• You must be between 18-45 years old
• You have Heavy Periods

You may not qualify if:

• You are pregnant
• You are currently using hormonal contraception or hormonal therapy
• You have a history of pelvic inflammatory disease (and have not had a normal pregnancy since)
• You had an infected abortion within the last three months
• You have abnormal or cancerous cells of the cervix or uterus
• You have an actine infection in your genital organs
• Known or suspected breast cancer
• Active liver disease or tumors
• Allergy to levonorgestrel or norethindrone
• You currently have deep vein thrombosis, pulmonary embolism, or history of these conditions
• you currently have active or recent (within the past year) arterial thromboembolic disease (such as a stroke or myocardial infarction) these conditions

Sponsors & Collaborators

• Scott and White Hospital & Clinic: lead

Study Sites (1)

Scott and White Hospital and Clinic

Temple, Texas, 76508, United States

RECRUITING

MeSH Terms

Conditions

Menorrhagia

Interventions

Norethindrone Acetate

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Norethindrone; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Patricia J Sulak, MD

  Scott and White Hospital & Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy M White, CCRP

CONTACT

254-724-8301; wewhite@swmail.sw.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 11, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 11, 2011

Record last verified: 2011-01

Locations

US (1)