Recruiting

Norethindrone with Levonorgestrel

Sponsor:

Scott and White Hospital & Clinic

Code:

NCT01391052

Conditions

Heavy Menstrual Bleeding

Menorrhagia

Hypermenorrhea

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Norethindrone acetate pretreatment

No pretreatment

Study Details

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

Study ID

NCT01391052

Start date

Jan, 2011

Status verified date

Jan, 2011

Completion date

Jan, 2013

Anticipated

Primary completion date

Jan, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Norethindrone acetate pretreatment

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

other: No pretreatment

LVN IUS is placed without norethindrone acetate pretreatment.

Interventions

Norethindrone acetate pretreatment

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

No pretreatment

LVN IUS is placed withour Norethindrone acetate pretreatment.

Primary outcome measure

  • Total number of bleeding days [ Time Frame: up to 180 days ]

Central Contacts and Locations

Central contacts

Wendy M White, CCRP

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

Locations

Scott and White Hospital and Clinic

Recruiting

Temple, Texas, United States, 76508

Contacts

Wendy M White, CCRP

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

Principal Investigator:

Patricia J Sulak, MD

More Information

Sponsor

Scott and White Hospital & Clinic

Last update posted

Jul 11, 2011

Last verified

Jan, 2011

Keywords

  • Intrauterine system
  • reproductive age
  • 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 Scott and White Hospital & Clinic on 2011-07-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.