Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia

PHASE4CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

September 30, 2015

Study Completion Date

October 31, 2015

Conditions
Menorrhagia
Interventions
DRUG

Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills

Each packet consists of a fixed dose of 30mcg estradiol and a 150mcg dose of levonorgestrel for the first 21 days of the cycle, followed by a 7 day pill free period. Subjects will be instructed to administer the pills orally, starting 5 days after the start of menstrual blood flow, continuing cyclically, thus allowing for withdrawal bleeding after the 21 day pill cycle.

DRUG

Naproxen sodium pills

As an alternative to oral contraceptive pills, subjects may take Naproxen 500 mg with onset of menses, then 250 mg three times daily for the duration of the menses (or maximum of five days)

DEVICE

NovaSure® Radiofrequency Endometrial Ablation

Radiofrequency endometrial ablation is performed in the outpatient surgery department. Subjects receive intravenous medication, determined by the attending anesthesiologist, sufficient to induce conscious sedation during the procedure.

Trial Locations (1)

55905

Mayo Clinic, Rochester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Hologic, Inc.

INDUSTRY

lead

Abimbola Famuyide

OTHER