PMID- 26217921
OWN - NLM
STAT- MEDLINE
DCOM- 20160617
LR  - 20201209
IS  - 1473-0766 (Electronic)
IS  - 0951-3590 (Linking)
VI  - 31
IP  - 7
DP  - 2015 Jul
TI  - Effectiveness, tolerability and acceptance of a low-dosed estradiol/dienogest 
      formulation (Lafamme 1 mg/2 mg) for the treatment of menopausal complaints: a 
      non-interventional observational study over 6 cycles of 28 days.
PG  - 560-4
LID - 10.3109/09513590.2015.1024220 [doi]
AB  - BACKGROUND: Concern and controversy characterize nowadays the use of hormone 
      therapy for management of patients with menopausal complaints. This observational 
      non-interventional study examined the use of a marketed oral formulation 
      containing 1 mg estradiol valerate and 2 mg dienogest for treatment of menopausal 
      symptoms in 1292 women visiting 243 gynecological practices in Germany. METHODS: 
      Score changes in the Menopausal Rating Scale (MRS) after three and six 28-day 
      cycles were primary endpoints. Subjective reports on skin- and hair-related 
      complaints and satisfaction with treatment effects were assessed. The incidence 
      of adverse drug reactions (ADRs), adverse events (AEs) and vaginal bleeding was 
      evaluated. RESULTS: MRS total score decreased substantially and stronger than the 
      clinically relevant change of 5 points (p < 0.0001) as compared with baseline. 
      Subjective skin- and hair-related complaints declined. No unexpected ADRs were 
      reported. AEs (including ADRs) were registered in 8.8% of the participants; most 
      frequent AEs/ADRs were postmenopausal hemorrhage (2.9%) and drug ineffective 
      (1.4%). Nearly 76% of the subjects remained amenorrheic. Approximately 90% of the 
      patients rated the medication's effectiveness/tolerability as good/very good; 84% 
      intended to continue the treatment. CONCLUSION: This low-dose estradiol/dienogest 
      formulation proved efficient and well-tolerated option for the alleviation of 
      menopausal symptoms associated with estrogen deficiency.
FAU - Rouskova, Daniela
AU  - Rouskova D
AD  - a Jenapharm GmbH & Co. KG, Medical Affairs , Jena , Germany and.
FAU - Mittmann, Katrin
AU  - Mittmann K
FAU - Schumacher, Ulrike
AU  - Schumacher U
FAU - Dietrich, Horst
AU  - Dietrich H
FAU - Zimmermann, Thomas
AU  - Zimmermann T
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20150728
PL  - England
TA  - Gynecol Endocrinol
JT  - Gynecological endocrinology : the official journal of the International Society 
      of Gynecological Endocrinology
JID - 8807913
RN  - 0 (Androgens)
RN  - 0 (Drug Combinations)
RN  - 0 (Estrogens)
RN  - 0 (estradiol valerate-dienogest)
RN  - 4TI98Z838E (Estradiol)
RN  - 6PG9VR430D (Nandrolone)
SB  - IM
MH  - Androgens/administration & dosage/adverse effects/*pharmacology
MH  - Drug Combinations
MH  - Estradiol/administration & dosage/adverse effects/*analogs & 
      derivatives/pharmacology
MH  - Estrogens/administration & dosage/adverse effects/*pharmacology
MH  - Female
MH  - Hormone Replacement Therapy/*methods
MH  - Humans
MH  - *Menopause/drug effects
MH  - Middle Aged
MH  - Nandrolone/administration & dosage/adverse effects/*analogs & 
      derivatives/pharmacology
MH  - Outcome Assessment, Health Care/*statistics & numerical data
MH  - Patient Outcome Assessment
OTO - NOTNLM
OT  - Estrogens
OT  - Menopause Rating Scale
OT  - hormone replacement therapy
OT  - menpopause
OT  - progesterone
EDAT- 2015/07/29 06:00
MHDA- 2016/06/18 06:00
CRDT- 2015/07/29 06:00
PHST- 2015/07/29 06:00 [entrez]
PHST- 2015/07/29 06:00 [pubmed]
PHST- 2016/06/18 06:00 [medline]
AID - 10.3109/09513590.2015.1024220 [doi]
PST - ppublish
SO  - Gynecol Endocrinol. 2015 Jul;31(7):560-4. doi: 10.3109/09513590.2015.1024220. 
      Epub 2015 Jul 28.