# TREATMENT EVALUATION IN PREMENSTRUAL SYNDROME PATIENTS

> **NIH NIH R01** · UNIVERSITY OF PENNSYLVANIA · 1994 · $252,383

## Abstract

The proposed project is a 5-year competing renewal of "Treatment
Evaluation in Premenstrual Syndrome Patients".  The purpose of these
studies is to a) determine the efficacy of selected anti-depressant,
hormonal and anxiolytic medications in treatment of premenstrual syndrome
(PMS) and b) determine the course and stability of premenstrual symptoms
and the extent to which they continue to impact the quality of life.
These studies relate to our working hypothesis that the mood and
behavioral changes of PMS derive from central effects, possibly an
altered CNS sensitivity to gonadal-adrenal steroids.

The specific aims are as follows:  1) Compare a serotonin-selective
antidepressant versus a noradrenergic anti-depressant to determine their
effects in PMS treatment; 2) Identify the effects of reduced A ring
metabolites of progesterone (allopregnanolone and pregnanolone) in PMS
subjects following oral micronized progesterone dose; 3) Complete the
current study comparing the efficacy or oral micronized progesterone and
the benzodiazepine alprazolam, both of which are postulated to potentiate
GABA transmission through binding to the GABA receptor complex, although
at different binding sites; 4) Determine the course and stability of PMS
symptoms following diagnosis and the impact of these symptoms on the
quality of life.

The methods to achieve these aims are 1) conduct a definitive randomized,
double-blind, placebo-controlled study of Sertraline and Desipramine in
PMS patients; 2) measure progesterone metabolites following double-
blinded oral progesterone dose and correlate metabolite levels behavioral
measures and treatment responses; 3) complete the current oral
progesterone/alprazolam/placebo efficacy study in the first continuation
year with sufficient sample size for definitive results; and 4) conduct
a long-term follow-up study of women diagnosed with PMS.

PMS is a complex, poorly understood, menstrually-related disorder
reported at severe levels by 5-10% of cycling women.  The sheer number
of these women in the prime ages of life would indicate that PMS is a
significant health problem that merits development of effective
treatments.  Additionally, the proposed studies will contribute to
understanding of neuroendocrine effects in PMS and the identification of
subgroups in the PMS population.  Information on the course of PMS
symptoms is important for understanding its occurrence and chronicity,
which reduces the quality of life and affects the use of costly medical
resources.

## Key facts

- **NIH application ID:** 2197695
- **Project number:** 5R01HD018633-10
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **SAM.gov UEI:** GM1XX56LEP58
- **Principal Investigator:** ELLEN W FREEMAN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 1994
- **Award amount:** $252,383
- **Award type:** 5
- **Project period:** 1985-02-01 → 1997-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/2197695

## Citation

> US National Institutes of Health, RePORTER application 2197695, TREATMENT EVALUATION IN PREMENSTRUAL SYNDROME PATIENTS (5R01HD018633-10). Retrieved via MORVS 2026-10-25 from https://api.morvs.ai/grant/nih/2197695. Licensed CC0.

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