TREATMENT EVALUATION IN PREMENSTRUAL SYNDROME PATIENTS

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The proposed project is a 5-year competing renewal of "Treatment Evaluation in Premenstrual Syndrome Patients". The specific aims of the project are to (1) complete the study of progesterone vaginal suppository treatment; (2) conduct a dose- response study of oral administration of micronized progesterone to determine an optimal dose and to determine if oral P elicits neuroendocrine and psychometric effects known to be associated with activation of the GABA-beta zeta -barbiturate receptor complex: (3) conduct a major treatment effectiveness study of 3 treatments -- oral progesterone, alprazolam and placebo; (4) test whether the treatment response is modified by high or low clinical contact during the treatment sequences; (5) evaluate treatments for 6 menstrual cycles to determine whether the presently observed trends in progesterone treatment are maintained or further increased. Aims 1-2 will be completed in Year 1; the treatment effectiveness study will be conducted in Years 2-5. The treatment study design is 3 parallel treatment sequences, each divided into high and low clinical contact under double-blind conditions. Random assignment to these treatments and contact groups will be made from the unimproved patients following evaluation and 2 placebo cycles. Two hundred forth women will complete the treatment sequences. Measures are at 10 times points using daily symptom reports, objective self-assessment instruments, physician and counselor evaluations. Descriptive and multivariate statistical methods are employed. There continues to be demand from both physicians and women who suffer from PMS (which may severely affect about 10% of reproductive-age females) for effective diagnosis and treatment of this disorder. This study will provide the following (1) definitive information on whether these treatments reduce PMS symptoms; (2) optimal dosage information for oral P; (3) further understanding of neuroendocrine and psychometric effects of oral P; (4) information on whether treatment response is modified by high or low clinical contact; (5) further diagnostic information on the symptom subgroups within the broad range of premenstrual symptoms.