Abstract | PURPOSE: To investigate the efficacy and safety of dienogest as a long-term treatment in endometriosis, with follow-up after treatment discontinuation. The study included women with endometriosis, who had previously completed a 12-week, placebo-controlled study of dienogest, who participated in an open-label extension study for up to 53 weeks. Thereafter, a patient subgroup was evaluated in a 24-week follow-up after treatment discontinuation. METHODS: A multicenter study performed in Germany, Italy and Ukraine. Women with endometriosis were enrolled at completion of the placebo-controlled study (n = 168). All women received dienogest (2 mg once daily, orally) and changes in pelvic pain (on a visual analog scale), bleeding pattern, adverse events and laboratory parameters were evaluated during and after treatment. RESULTS: The completion rate among women who entered the open-label extension study was 90.5% (n = 152). A significant decrease in pelvic pain was shown during continued dienogest treatment (P < 0.001). The mean frequency and intensity of bleeding progressively decreased. Adverse events, rated generally mild or moderate, led to withdrawal in four patients (2.4%). No clinically relevant changes in laboratory parameters were observed. During treatment-free follow-up (n = 34), the reduction in pelvic pain persisted, while bleeding frequency and intensity returned to normal patterns. CONCLUSIONS: Long-term dienogest showed a favorable efficacy and safety profile, with progressive decreases in pain and bleeding irregularities during continued treatment; the decrease of pelvic pain persisted for at least 24 weeks after treatment cessation.
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Authors | Felice Petraglia, Daniela Hornung, Christian Seitz, Thomas Faustmann, Christoph Gerlinger, Stefano Luisi, Lucia Lazzeri, Thomas Strowitzki |
Journal | Archives of gynecology and obstetrics
(Arch Gynecol Obstet)
Vol. 285
Issue 1
Pg. 167-73
(Jan 2012)
ISSN: 1432-0711 [Electronic] Germany |
PMID | 21681516
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Hormone Antagonists
- dienogest
- Nandrolone
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Topics |
- Adolescent
- Adult
- Drug Administration Schedule
- Endometriosis
(drug therapy)
- Female
- Follow-Up Studies
- Germany
- Hormone Antagonists
(administration & dosage)
- Humans
- Italy
- Middle Aged
- Nandrolone
(administration & dosage, analogs & derivatives)
- Pelvic Pain
- Ukraine
- Young Adult
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