Long-term safety and tolerability of continuous-combined hormone therapy in postmenopausal women: results from a seven-year randomised comparison of low and standard doses

Heikkinen, Jorma; Vaheri, Raija; Timonen, Ulla
September 2004
Journal of the British Menopause Society;2004, Vol. 10 Issue 3, p95
Academic Journal
Objective. To establish the long-term safety profile of four oestradiol valerate/medroxyprogesterone acetate (E2V/MPA) regimens. Study design. 419 postmenopausal women in parallel treatment groups started treatment with 1 or 2 mg E2V with either 2.5 or 5 mg MPA for 84 cycles of 28 days in a randomised, comparative study. The first 24 month double-blind efficacy period has been previously reported. This report focuses on the open safety period after the first two years until completion of 84 treatment cycles. Results. A total of 275 women (65.6%) completed the seven-year study. All regimens provided good bleeding control and endometrial protection, with no cases of endometrial hyperplasia or cancer diagnosed. All regimens were well tolerated with a low frequency of adverse effects, mostly occurring within the first two years. The most common drug-related adverse events included breakthrough bleeding, headache/migraine, abdominal pain and mood changes. Very few women (n = 4) receiving the lowest dose option (1 mg E2V + 2.5 mg MPA) reported adverse effects (p<0.009 vs other groups). No serious cardiovascular events occurred in any of the groups, the incidence of strokes was lower than the national incidence for the age group and the incidence of breast cancer was comparable with the national incidence (95% CI). In the lowest dose group, no women had to stop therapy prematurely due to serious adverse events. Conclusions. The results support the use of lower doses for longterm hormone therapies.


Related Articles

  • Prolonged endometrial stimulation associated with oestradiol implants. Gangar, Kevin F.; Fraser, David; Whitehead, Malcolm I.; Cust, Michael P. // BMJ: British Medical Journal (International Edition);2/17/90, Vol. 300 Issue 6722, p436 

    Provides information on endometrial stimulation after discontinuation of treatment with oestradiol implants. Stimulatory effects of implantation; Duration of the stimulation; Avoidance of hyperplasia and carcinoma.

  • Purulent Vaginal Discharge Secondary to Ureteral Ectopia. Narayan, Aditee; Wiener, John S. // Clinical Pediatrics;Sep2009, Vol. 48 Issue 7, p773 

    The article presents a case study of a three-year-old girl who was taken to the emergency room due to vaginal discharge and bleeding, fever, and abdominal pain. According to her medical records and surgical observations, the vaginal discharge was infected fluid from a left pyoureter with ectopic...

  • Efficacy of neodymium:YAG laser therapy for gastric antral vascular ectasia (GAVE) following hematopoietic cell transplant. Selinger, R. R. E.; McDonald, G. B.; Hockenbery, D. M.; Steinbach, G.; Kimmey, M. B. // Bone Marrow Transplantation;Jan2006, Vol. 37 Issue 2, p191 

    We determined the incidence of severe bleeding from gastric antral vascular ectasia (GAVE) after myeloablative hematopoietic cell transplant and the outcomes after treatment with endoscopic neodymium:YAG laser photocoagulation. From 1992 to 2005, the incidence of severe bleeding from GAVE was...

  • Laparoscopic management of primary abdominal pregnancy: a case report.  // Journal of the Turkish-German Gynecological Association;Dec2010, Vol. 11 Issue 4, p220 

    No abstract available.

  • Small cell carcinoma of the endometrium with concomitant pelvic inflammatory disease. Chuang, J.; Chu, C.-C.; Hwang, J.-L.; Cheng, W.-C. // Archives of Gynecology & Obstetrics;Jul2002, Vol. 266 Issue 3, p178 

    Background: Small cell carcinoma of the endometrium is a rare disease entity characterized by bulkiness and predisposition to necrosis. Clinical presentations include postmenopausal bleeding, lower abdominal mass, chronic abdominal pain and menorrhagia. We present a case of small cell carcinoma...

  • Clofazimine.  // Reactions Weekly;3/26/2011, Issue 1344, p12 

    The article describes the case of a 27-year-old woman who developed abdominal pain and gastrointestinal hemorrhage after receiving clofazimine.

  • Ethinylestradiol/norgestimate.  // Reactions Weekly;1/9/2010 Part 1 of 2, Issue 1283, p39 

    The article describes the case of a 13-year-old female patient who suffered from a large decidual cast while being treated with ethinylestradiol/norgestimate for adolescent menorrhagia. After being hospitalized, the girl experienced severe abdominal pain and moderate bleeding. All examinations...

  • 10 tips on… endometriosis. Williams, Nerys // Practice Nurse;8/18/2006, Vol. 32 Issue 3, p32 

    The article presents several tips on endometriosis. Endometriosis is defined histopathologically as the presence of ectopic endometrium outside the myometrium and the endometrial cavity of the uterus. Endometriosis can occur at any stage of reproductive life. Endometriosis may be asymptomatic...

  • Acute appendicitis caused by endometriosis: a case report.  // Journal of Medical Case Reports;2011, Vol. 5 Issue 1, p1 

    The article presents a case study of a 25-year old woman with abdominal pain, nausea and vomiting. It states that acute appendicitis was diagnosed for which appendectomy was performed. It mentions that small nodules were found in the appendix wall and eventually appendiceal endometriosis was...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics