The efficacy and tolerability of Valette: a postmarketing surveillance study

Thomas Zimmermann, T Zimmermann, H. Dietrich, K H Wisser, Hermann Hoffmann, H Hoffmann
The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception · 1999 · vol. 4(3) , pp. 155–164 · doi:10.1080/13625189909040810 · PMID:10574641 · W2091098879
Other OA: closed CC0 ⤵ 12 in-corpus citations
View on OpenAlex View on PubMed View at publisher
⚙ AI-generated summary by gemini-2.5-flash-lite, 2026-06-08 ⓘ

This postmarketing study found Valette (dienogest/ethinylestradiol) demonstrated excellent contraceptive efficacy and cycle control with good tolerability in routine gynecological practice.

One-sentence paraphrase of the abstract; not a substitute for reading it. No clinical advice. How this works

Abstract

OBJECTIVES AND METHODS: A postmarketing survey was carried out to determine the efficacy and tolerability of Valette (dienogest 2.0 mg and ethinylestradiol 0.03 mg) in routine gynecological practice. RESULTS: Valette had excellent contraceptive efficacy (unadjusted Pearl index 0.14), with 11 unplanned pregnancies from a total of 92 146 cycles of exposure, of which at least four were attributable to user failure. Cycle control was good, with spotting and breakthrough bleeding, which affected 5.0% and 3.4% of women, respectively, during the first cycle, becoming less frequent thereafter. Silent menstruation, i.e. the absence of withdrawal bleeding, affected on average 2.0% of women per cycle and 5.9% within the observation period. Valette was well tolerated. The most common adverse drug reactions were mastalgia (1.46% of all users), weight gain (1.11%), headache (0.98%), nausea/vomiting (0.96%), dysmenorrhea (0.35%), decreased libido (0.31%) and depressive moods (0.28%). The dropout rate due to adverse drug reactions was only 3.2%. Only six of the 16 267 women reported events which were considered to be serious adverse drug reactions; all recovered with appropriate treatment. CONCLUSIONS: These results confirm those from previous clinical trials, and demonstrate that Valette is highly effective, very well tolerated and produces excellent cycle control in routine practice.

My notes (saved in your browser only)

Condition tags

dysmenorrhea

MeSH descriptors

Contraceptives, Oral, Combined Ethinyl Estradiol Menstruation Nandrolone Adolescent Adult Contraceptives, Oral, Combined Contraceptives, Oral, Combined Dose-Response Relationship, Drug Estradiol Congeners Estradiol Congeners Estradiol Congeners Ethinyl Estradiol Ethinyl Estradiol Female Germany Hormone Antagonists Hormone Antagonists Hormone Antagonists Humans

Citation neighborhood (2-hop)

Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. Outer rings show 2-hop neighbours — papers reached through the immediate citers/citees. [ collapse to 1-hop ]

References (21)

Cited by (11)

Source provenance

openalex
last seen: 2026-05-10T10:41:41.225191+00:00
pubmed
last seen: 2026-10-08T20:59:14.592962+00:00
unpaywall
last seen: 2026-10-22T06:24:31.118836+00:00
License: CC0 · commercial use OK