Clinical Data about Women with Menorrhagia

An estimated 7 million women in the United States suffer from excessive menstrual bleeding. While not life threatening, menorrhagia may nonetheless be severely debilitating for women, resulting in pain, fatigue, emotional turmoil, embarrassment, and anemia.

According to a recent National Women’s Health Resource Center survey1, the condition greatly disrupts women’s daily lives:

56% of women find they have to make significant adjustments in their lives when they have their period

4 out of 5 women with heavy periods say they have missed sex because of their period

85% of women report feeling fatigue or tiredness during their periods

50% of women self-medicate with OTC remedies

Abnormal uterine bleeding is a significant medical problem and accounts for up to 1/3 of out patient gynecologic visits annually2.

However, an estimated 5 million women suffer silently with the condition and need to be engaged in a dialogue about menorrhagia and the treatment options available.

Menorrhagia - Undiagnosed and Undertreated

  • In the US alone, menorrhagia affects approximately 1 in 4 women aged 35 to 55 years3
  • 71% of women do not discuss their menorrhagia symptoms with their physician3 and as a result many women do not receive treatment.

Hormones don't reliably help with heavy menstrual bleeding

53% of women failed to achieve normal bleeding2

Results from a 3-month randomized, controlled clinical trial of a 35 mcg ethinyl estradiol formulation

Hormone Therapy can take months to achieve bleeding control11,4

OCs - 3 months required to see reductions in bleeding.11   Hormone-eluting IUD - up to 6 months required to achieve bleeding control.4

With Medical Management Treatment Failure is High, Resulting in Additional Intervention6,7

NovaSure for Heavy Menstrual Bleeding: Clinical Data
Data from a 5-year study of menorrhagia with women randomized to receive medical therapy or transcervical resection (N=144). Medical therapies included OCs, progestins, an antifibrinolytic, GnRH agonist or HRT.   Data from a 5-year, randomized, controlled study of women with menorrhagia (N=119). Women were randomized to LNG-IUS or hysterectomy.

NovaSure provides reliable relief from heavy menstrual bleeding and avoids additional intervention for 97% of patients7

NovaSure for Heavy Menstrual Bleeding: Clinical Data

Results from a 3-year prospective, observational pilot study of premenopausal
women with menorrhagia secondary to DUB (N= 107)


NovaSure gives women the results they want with the treatment
option they prefer

NovaSure for Heavy Menstrual Bleeding: Clinical Data
Safe
More than 400,000 women treated.1		   Successful
More than 9 out of 10 women return to normal or lower than normal bleeding levels.9		   Sooner
Rapid recovery time with 97% of patients experiencing no post-procedural pain.10

References: 1. The National Women's Health Resource Study of 653 women aged 35-49, September 29-October 12, 2005 2. Davis A, Godwin A, Lippman J, et al. Triphasic norgestimate-ethinyl estradiol for treating dysfunctional uterine bleeding. Obstet Gynecol 2000; 96:913-920. 3. Data on file. Cytyc Corporation; Marlborough, MA. 4. Busfield R, Farquhar C, Sowter M, et al. A randomised trial comparing the levonorgestrel intrauterine system and thermal balloon ablation for heavy menstrual bleeding. BJOG 2006; 113:257-263. 5. Cooper K, Jack S, Parkin D, Grant A. Five-year follow up of women randomised to medical management or transcervical resection of the endometrium for heavy menstrual loss: clinical and quality of life outcomes. Br J Obstet Gynaecol 2001; 108:1222-1228. 6. Hurskainen R, Teperi J, Rissanen P, et al. Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system of hysterectomy for treatment of menorrhagia: randomized trial 5-year follow-up. JAMA 2004; 291:1456-1463. 7. Gallinat A. NovaSure impedance controlled system for endometrial ablation: Three-year follow-up on 107 patients. Am J Obstet Gynecol 2004; 191:1585-1589. 8. Cytyc, Data on file. BioVid, 2004 Nov/Dec. 9. Cooper J, Gimpelson R, Laberge P, et al. A randomized, multicenter trial of safety and efficacy of the NovaSure system in the treatment of menorrhagia. J Am Assoc Gynecol Laparosc 2002; 9(4):418-428. 10. NovaSure Instructions For Use. 11. ACOG Practice Bulletin No. 14: Management of anovulatory bleeding. Int J Gynecol Obstet 2001; 72:263-271.