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

NCT01165307 | Completed Phase 4 Results DMC

• 1 other identifier: 08-007334
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Excessive menstrual loss (menorrhagia) is a common condition that affects women of reproductive age, and can result in anemia, chronic fatigue and lost wages from work. The traditional first line management involves treatment with oral contraceptives or non-steroidal anti-inflammatory agents. Many women ultimately undergo hysterectomy, a major operative procedure associated with increased costs, loss of feeling of womanhood, debilitating complications and on rare occasions, death. The newer global endometrial ablation (GEA) devices allow the destruction of the endometrial lining, without the removal of the uterus, in an ambulatory surgery setting. GEA offers a safe and effective alternative to hysterectomy with minimal risks and without unpleasant side-effects. Presently, global endometrial ablation is offered as an alternative to hysterectomy, after medical intervention has failed. This study will determine the role of global endometrial ablation in the initial management of menorrhagia. Women seeking treatment for menorrhagia will be randomized to either the medical treatment arm or the global endometrial ablation arm. This study will be the first to compare clinical efficacy and costs between oral contraceptive pills and global endometrial ablation in the initial management of menorrhagia and could potentially change the management of menorrhagia and impact millions of women who suffer from this condition.

Conditions

Menorrhagia

Keywords

Menorrhagia; Endometrial ablation; Heavy menstrual bleeding

Outcome Measures

Primary Outcomes (1)

• Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC).

  The PBLAC is a simple, pictorial tool used in women with menorrhagia to assess menstrual blood loss. The total score is calculated by adding up the sum of all scores for the tampons or sanitary napkin used in the menstrual cycle. For tampons: 1 for lightly stained, 5 for moderately soiled and 10 for completely saturated tampons. For sanitary napkins: 1 for lightly stained, 5 for moderately soiled, and 20 for completely saturated pads. Clots were given a score of 1 for small and 5 for large clots. Abnormal PBLAC bleeding score greater than or equal to 100, which correlates with menorrhagia, defined as greater than 80 mL of menstrual blood loss. Normal bleeding is defined as a score of 75 or less. A score of 0 indicates amenorrhea, or absence of menstruation.

  Measured at 12 months following initial treatment

Secondary Outcomes (11)

• Quality of Life Score Using the Short Form-12 (SF-12) Health Survey

  Measured at 12 months following initial treatment

• Quality of Life as Measured by the Menorrhagia Multi-Attribute Scale (MMAS )

  Measured at 12 months following initial treatment

• Hemoglobin at 12 Months

  Measured at 12 months following initial treatment

• Change in Hemoglobin

  baseline, 12 months

• Ferritin at 12 Months

  Measured at 12 months following initial treatment

Study Arms (2)

Medical Therapy

ACTIVE COMPARATOR

Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).

Drug: Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills; Drug: Naproxen sodium pills

Radiofrequency Endometrial Ablation

ACTIVE COMPARATOR

Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.

Device: NovaSure® Radiofrequency Endometrial Ablation

Interventions

Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills DRUG

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.

Also known as: Nordette®

Medical Therapy

Naproxen sodium pills DRUG

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)

Also known as: Naprosyn 250 mg tablets

Medical Therapy

NovaSure® Radiofrequency Endometrial Ablation DEVICE

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.

Radiofrequency Endometrial Ablation

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult female, ages 30-55, who is pre-menopausal and for whom childbearing is complete
• Subjective symptom of excessive menstrual loss
• Normal uterine cavity length (≥ 4cm) with a sound measurement of ≤10cm documented by sonohysterogram or hysteroscopy in the preceding 6 months
• At least one normal Pap Test and no unexplained abnormal Pap Tests within 6 months of procedure
• Prior history of permanent sterilization or use of reliable non-hormonal contraception during the 14 month study period or history of vasectomy in partner
• Freely agree to participate in the study including all study related procedures and evaluations, and document this agreement by signing the informed consent document

You may not qualify if:

• Pregnancy or desire for future childbearing
• Active lower genital infection at the time of procedure
• Active urinary tract infection at the time of procedure
• Active pelvic inflammatory disease (PID) or recurrent chronic PID
• Endometrial neoplasia, determined by endometrial biopsy taken within 12 months of study entry
• Current or past history of cervical or endometrial cancer
• Uterine sound measurement greater than 10cm
• Submucous leiomyoma greater than 2cm or cavity distorting leiomyoma
• History of myomectomy or classical cesarean section
• Previous endometrial ablation
• Oral hormonal treatment in the preceding 3 months, hormone releasing intrauterine contraceptive in the preceding month, or injectable hormone treatment in the preceding 12 months
• Contraindication to hormonal therapy and non-steroidal anti-inflammatory agents.
• History of a coagulopathy or endocrinopathy
• Inability to follow up at 12 months

Sponsors & Collaborators

• Abimbola Famuyide: lead
• Hologic, Inc.: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Famuyide AO, Laughlin-Tommaso SK, Shazly SA, Hall Long K, Breitkopf DM, Weaver AL, McGree ME, El-Nashar SA, Lemens MA, Hopkins MR. Medical therapy versus radiofrequency endometrial ablation in the initial treatment of heavy menstrual bleeding (iTOM Trial): A clinical and economic analysis. PLoS One. 2017 Nov 15;12(11):e0188176. doi: 10.1371/journal.pone.0188176. eCollection 2017.

  PMID: 29141040 DERIVED

MeSH Terms

Conditions

Menorrhagia

Interventions

Estradiol; Levonorgestrel; Ethinyl Estradiol-Norgestrel Combination; Naproxen

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)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Ethinyl Estradiol; Norpregnatrienes; Estrogenic Steroids, Alkylated; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Abimbola O. Famuyide
• Organization: Mayo Clinic

Famuyide.Abimbola@mayo.edu

507-284-7035

Study Officials

• Abimbola O. Famuyide, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant, Assistant Professor of Obstetrics-Gynecology

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 19, 2010
• Study Start: August 1, 2009
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 20, 2017
• Results First Posted: November 15, 2016

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)