Stopping Heavy Periods Project

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Women and Infants Hospital of Rhode Island
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Estradiol; Ethinyl Estradiol; Levonorgestrel

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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