Biomaterial Database

The effect of dydrogesterone on premenstrual symptoms. A double-blind, randomized, placebo-controlled study in general practice. 1988

V Hoffmann, and P A Pedersen, and J Philip, and P Fly, and C Pedersen

A/S Ferrosan, Søborg, Denmark.

The effect of dydrogesterone on premenstrual symptoms was investigated in a double-blind, randomized, placebo-controlled study comprising 161 patients from unselected practice material. Dydrogesterone 10 mg twice daily from the 12th day until onset of the following menstrual period was compared with placebo throughout 3 cycles. No clinically relevant effect of dydrogesterone was found. There was an overall therapeutic effect in 52% of the patients on dydrogesterone, and in 44% of the placebo-treated patients. Therapeutic gain ranged between -7 and +23% (95% confidence limits). Type II error risk of failure to detect a therapeutic gain of 20% was 6%. A significant effect of dydrogesterone was found on decreased libido, and statistical significance was nearly achieved for the symptoms irritability and headache. The significant effect on libido can be attributed to mass significance.

UI	MeSH Term	Description	Entries
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D011293	Premenstrual Syndrome	A combination of distressing physical, psychologic, or behavioral changes that occur during the luteal phase of the menstrual cycle. Symptoms of PMS are diverse (such as pain, water-retention, anxiety, cravings, and depression) and they diminish markedly 2 or 3 days after the initiation of menses.	Premenstrual Tension,Premenstrual Syndromes,Premenstrual Tensions,Syndrome, Premenstrual,Syndromes, Premenstrual,Tension, Premenstrual,Tensions, Premenstrual
D011897	Random Allocation	A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.	Randomization,Allocation, Random
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004394	Dydrogesterone	A synthetic progestational hormone with no androgenic or estrogenic properties. Unlike many other progestational compounds, dydrogesterone produces no increase in temperature and does not inhibit OVULATION.	Isopregnenone,6-Dehydro-9 beta-10 alpha-progesterone,Dehydrogesterone,Duphaston,6 Dehydro 9 beta 10 alpha progesterone
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000284	Administration, Oral	The giving of drugs, chemicals, or other substances by mouth.	Drug Administration, Oral,Administration, Oral Drug,Oral Administration,Oral Drug Administration,Administrations, Oral,Administrations, Oral Drug,Drug Administrations, Oral,Oral Administrations,Oral Drug Administrations
D000293	Adolescent	A person 13 to 18 years of age.	Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths