Phase 4
N=67
Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia
Menorrhagia
Bottom Line
View on ClinicalTrials.gov: NCT01165307 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC). — 15; 0 units on a scale — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills (Drug); Naproxen sodium pills (Drug); NovaSure® Radiofrequency Endometrial Ablation (Device)
- Age
- Adult · 30+ yrs
- Sex
- Female
- Sponsor
- Abimbola Famuyide
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC). |
15; 0 | 0.003 sig |
| SECONDARY Quality of Life Score Using the Short Form-12 (SF-12) Health Survey |
54.2; 54.5; 49.8; 53.8 | 0.82 |
| SECONDARY Quality of Life as Measured by the Menorrhagia Multi-Attribute Scale (MMAS ) |
100; 100 | 0.12 |
| SECONDARY Hemoglobin at 12 Months |
13.2; 13.4 | 0.38 |
| SECONDARY Change in Hemoglobin |
0.0; 0.5 | 0.12 |
| SECONDARY Ferritin at 12 Months |
25.0; 26.5 | 0.60 |
| SECONDARY Change in Ferritin From Baseline |
4.0; 10.0 | 0.42 |
| SECONDARY Direct Medical Costs |
1300; 3494; 1601; 1837 | — |
| SECONDARY Indirect Medical Costs |
741; 124; 264; 27; 968; 138 | — |
| SECONDARY Bleeding Pattern at 12 Months |
5; 16; 4; 6; 2; 0 | — |
| SECONDARY Pain at 12 Months as Measured by the Pain Visual Analog Scale (VAS) |
0.4; 0.0 | 0.08 |
| SECONDARY Subject Satisfaction at 12 Months |
12; 30; 4; 1; 2; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01165307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.