PMID- 24905727
OWN - NLM
STAT- MEDLINE
DCOM- 20150608
LR  - 20140922
IS  - 1473-0766 (Electronic)
IS  - 0951-3590 (Linking)
VI  - 30
IP  - 10
DP  - 2014 Oct
TI  - Effectiveness, tolerability and acceptance of an oral estradiol/levonorgestrel 
      formulation for the treatment of menopausal complaints: a non-interventional 
      observational study over six cycles of 28 days.
PG  - 712-6
LID - 10.3109/09513590.2014.925867 [doi]
AB  - BACKGROUND: Use of hormone therapy for menopausal complaints is a subject of 
      controversy and increased uncertainty and concerns. This non-interventional study 
      aimed to investigate a marketed oral formulation containing 1 mg estradiol and 
      0.04 mg levonorgestrel for continuous treatment of menopausal symptoms for 
      approximately 6 months in women visiting gynecological practices in Germany. 
      METHODS: Changes in the menopause rating scale (MRS) total and sub-domain scores 
      after three and six 28-d cycles served as primary endpoint. Skin- and 
      hair-related complaints, quality of sexual life and subjective satisfaction with 
      the treatment were assessed. Adverse drug reactions (ADRs), adverse events (AEs) 
      and vaginal bleeding were evaluated. RESULTS: MRS scores improved significantly 
      above 5 points of clinical relevance as compared to baseline (n = 736, 
      p < 0.0001). Skin- and hair-related symptoms abated; quality of sexual life 
      improved. AEs were registered in 9.9% of the participants. No unexpected ADRs 
      were reported. Bleeding episodes consistently decreased; >75% of the subjects 
      were amenorrheic throughout the study. Medication's effectiveness and 
      tolerability was rated very good/good by >80% of the participants, who also 
      continued treatment. CONCLUSION: This estradiol/low-dose levonorgestrel 
      formulation safely alleviates menopausal symptoms in peri- and postmenopausal 
      women with add-on benefits regarding dermatological and sexual life complaints.
FAU - Rouskova, Daniela
AU  - Rouskova D
AD  - Medical Affairs, Jenapharm GmbH & Co. KG , Jena , Germany.
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 - 20140606
PL  - England
TA  - Gynecol Endocrinol
JT  - Gynecological endocrinology : the official journal of the International Society 
      of Gynecological Endocrinology
JID - 8807913
RN  - 0 (Drug Combinations)
RN  - 0 (Estrogens)
RN  - 0 (Progestins)
RN  - 4TI98Z838E (Estradiol)
RN  - 5W7SIA7YZW (Levonorgestrel)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Drug Combinations
MH  - Estradiol/administration & dosage/adverse effects/*pharmacology
MH  - Estrogens/administration & dosage/adverse effects/*pharmacology
MH  - Female
MH  - Germany
MH  - Hormone Replacement Therapy/*methods/psychology/standards
MH  - Humans
MH  - Levonorgestrel/administration & dosage/adverse effects/*pharmacology
MH  - Menopause/drug effects/*physiology/psychology
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Progestins/administration & dosage/adverse effects/*pharmacology
MH  - Severity of Illness Index
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Estradiol/levonorgestrel
OT  - menopausal hormone therapy
OT  - menopause
OT  - menopause rating scale
OT  - non-interventional study
EDAT- 2014/06/07 06:00
MHDA- 2015/06/09 06:00
CRDT- 2014/06/07 06:00
PHST- 2014/06/07 06:00 [entrez]
PHST- 2014/06/07 06:00 [pubmed]
PHST- 2015/06/09 06:00 [medline]
AID - 10.3109/09513590.2014.925867 [doi]
PST - ppublish
SO  - Gynecol Endocrinol. 2014 Oct;30(10):712-6. doi: 10.3109/09513590.2014.925867. 
      Epub 2014 Jun 6.