Extrait

Background and study aims The menopause is when a woman stops having periods and is no longer able to get pregnant naturally. This is a natural part of the aging process that usually happens when a women is around 50 years old. At this time, a woman’s oestrogen (female hormone) levels decline, leading to a range of symptoms, including hot flushes, sleep disturbances, and mood swings. There is a lot of evidence showing that the decline in oestrogen can be linked with an increased risk of heart disease and osteoporosis (brittle bones). One way of preventing this is by taking medication to replace the depleted osetrogen (hormone replacement), however this is unpopular. Klimaktoplant H is a medication used to treat menopausal symptoms without use of hormones. The aim of this study is to find out if taking Klimaktoplant H is an effective way of reducing menopausal symptoms. Who can participate? Women aged 40-55 years who are going through the menopause. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group take two tablets containing Klimaktoplant H three times a day for 12 weeks. Those in the second group two tablets containing a placebo (dummy drug) three times a day for 12 weeks. Over the 12 weeks of the study, participants in both groups are regularly assessed in order to find out whether the Klimaktoplant H has had any effect on menopause symptoms. What are the possible benefits and risks of participating? Participants who are treated with Klimaktoplant H may benefit from a reduction in their menopausal symptoms. There is a risk for those taking Klimaktoplant H of side effects, such as allergic reactions, nosebleeds, and restarting menstrual bleeding. Where is the study run from? Six medical practices in Kiev (Ukraine) When is the study starting and how long is it expected to run for? December 2000 to January 2004 Who is funding the study? Deutsche Homöopathie-Union (DHU)-Arzneimittel GmbH & Co. KG (Germany) Who is the main contact? Ms Julia Burkart

Critère d'inclusion

• Acute menopausal complaints

Liens

• isrctn