Abstract | OBJECTIVES: METHODS: A prospective, randomized, open-label study was conducted in nine centres in Canada. Healthy women over 30 years of age suffering from idiopathic menorrhagia were treated either with LNG-IUS (n = 20) or with OC1/20 (n = 19) over 12 months. The primary endpoint was the change in MBL from baseline to 12 months. Secondary endpoints included treatment success (defined as a MBL score < 100 after 12 months), hemoglobin levels, and the menorrhagia severity score. RESULTS: In both treatment groups, MBL decreased significantly from baseline to 12 months (P < 0.001). For the primary endpoint, the MBL score decreased significantly more in the LNG-IUS group (median from 228 to 13, mean percent change-83%) compared to the OC1/20 group (median from 290 to 72; mean percent change-68%) (P = 0.002) after 12 months. In the LNG-IUS group, 80% of subjects had treatment success compared with 36.8 % in the OC1/20 group (P < 0.009). Both treatments increased hemoglobin concentrations significantly between baseline and 12 months. The menorrhagia severity score was consistently lower in the LNG-IUS group at all study time points and was significantly lower (P = 0.045) at six months. Both treatments were well tolerated. CONCLUSION: Both the LNG-IUS and the combined oral contraceptive effectively decreased menstrual blood loss in women with idiopathic menorrhagia. The overall clinical benefit was more pronounced with LNG-IUS than with OC1/20.
|
Authors | Jan Endrikat, Heather Shapiro, Eeva Lukkari-Lax, Michael Kunz, Werner Schmidt, Michel Fortier |
Journal | Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC
(J Obstet Gynaecol Can)
Vol. 31
Issue 4
Pg. 340-347
(Apr 2009)
ISSN: 1701-2163 [Print] Netherlands |
PMID | 19497153
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Estrogens
- Hemoglobins
- Ethinyl Estradiol
- Levonorgestrel
- Norethindrone Acetate
- Norethindrone
|
Topics |
- Adult
- Canada
- Contraceptive Agents, Female
(administration & dosage)
- Contraceptives, Oral, Synthetic
(therapeutic use)
- Estrogens
(therapeutic use)
- Ethinyl Estradiol
(therapeutic use)
- Female
- Hemoglobins
(analysis)
- Humans
- Intrauterine Devices, Medicated
- Levonorgestrel
(administration & dosage)
- Menorrhagia
(drug therapy)
- Norethindrone
(analogs & derivatives, therapeutic use)
- Norethindrone Acetate
- Prospective Studies
- Severity of Illness Index
|