Stopping Heavy Periods Project

NCT02002260 | Unknown DMC

• 1 other identifier: R01HD074751
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized clinical trial comparing the effectiveness of the levonorgestrel intrauterine system (LNG-IUS) to combined oral contraceptives (COCs) for improving quality of life among women who report heavy menstrual bleeding.

Conditions

Abnormal Uterine Bleeding; Abnormal Uterine Bleeding, Ovulatory Dysfunction; Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction

Outcome Measures

Primary Outcomes (1)

• Menstrual Bleeding Questionnaire

  We will measure bleeding-specific quality of life using the Menstrual Bleeding Questionnaire (MBQ), a validated tool to assess bleeding-related quality of life, which is the most important outcome for patients and for clinicians treating this symptom. We will measure MBQ score at randomization, and at 6 weeks, 3 month, 6 months, and 12 months post-randomization for both groups

  Completed 5 times over a one year time period

Secondary Outcomes (1)

• Treatment Failure

  Information collected at four time points during a one year period post randomization

Study Arms (2)

Levonorgestrel intrauterine system

ACTIVE COMPARATOR

levonorgestrel intrauterine system with 52 mg of levonorgestrel, levonorgestrel is released at a rate of approximately 20 μg/day. Inserted once, duration 5 years.

Device: Levonorgestrel intrauterine system

Combined oral contraceptives

ACTIVE COMPARATOR

A combined ethinyl estradiol (ee) and progestin oral contraceptive pill chosen by the participants' primary gynecologic care provider. Monophasic with 30 or 35 mcg ee administered according to pill pack instructions (21 days active pills, 7 placebo pills)

Drug: Combined oral contraceptives

Interventions

Levonorgestrel intrauterine system DEVICE

Also known as: Mirena

Levonorgestrel intrauterine system

Combined oral contraceptives DRUG

Also known as: Any combined oral contraceptive of the provider's choice so long, as it contains 30-35 mg of ethinyl estradiol.

Combined oral contraceptives

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Self-reported heavy menstrual bleeding
• Age 18-51 years
• Etiology of heavy menstrual bleeding from either ovulatory disorders (AUB-O) or endometrial hemostatic disorders (AUB-E)

You may not qualify if:

• Plan pregnancy in the next year
• Menopausal
• Currently has a copper IUD in place
• History of ablation or hysterectomy or have any contraindications to COCs or LNG-IUS

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Gynecologic practices affiliated with Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Metrorrhagia

Interventions

Contraceptives, Oral, Combined; Ethinyl Estradiol

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

Intervention Hierarchy (Ancestors)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Kristen A Matteson, M.D., M.P.H.

  Women and Infants Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 5, 2013
• Study Start: February 1, 2013
• Primary Completion: June 16, 2019
• Study Completion: December 31, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

US (1)