Investigational oral contraceptive reduces premenstrual and menstrual symptoms

April 30, 2001

Study subjects report decreases in moodiness, irritability, water retention and appetite

Chicago, IL, May 1, 2001 - Results from a study presented today by Candace Brown, Pharm.D., CFNP, at the American College of Obstetricians and Gynecologists 2001 Annual Clinical Meeting demonstrate that Yasmin(R) (drospirenone 3 mg and ethinyl estradiol 0.030 mg), an investigational low-dose, monophasic oral contraceptive, provides relief from some of the most common physical and emotional symptoms associated with the menstrual cycle, including negative mood, water retention and increased appetite.

"Premenstrual symptoms are very real and affect up to 80 percent of women in this country. Some women are so severely affected that their ability to function in their day-to-day lives becomes impaired," said Candace Brown, Professor, Departments of Pharmacy Practice, Ob/Gyn and Psychiatry at the University of Tennessee Health Science Center. "Treatment options for women who suffer from these symptoms to any degree are important and necessary. These data suggest that using the oral contraceptive Yasmin reduces premenstrual and menstrual symptoms, and that is very good news for many women."

Yasmin is the only oral contraceptive to contain drospirenone, a progestin that is different from the progestins currently available in other oral contraceptives. Because it is an analogue of spironolactone, drospirenone exhibits antimineralocorticoid activity, which prevents the action of the hormones responsible for sodium and water retention, in addition to antiandrogenic properties, which in animal studies inhibited the effects of male sex hormones.

Study Design
In this six-month, open-label study, which was part of a 13-month multicenter evaluation of Yasmin as an oral contraceptive, 326 women aged 18 to 35 years were given Yasmin for 13 cycles. Subjects completed a 23-item, self-rating Women's Health Assessment Questionnaire (WHAQ) at baseline and at the end of six treatment cycles, for three phases of the menstrual cycle (premenstrual, menstrual and postmenstrual). The questionnaire, designed to assess the impact of Yasmin on a woman's self-perception of menstrual symptoms, was a subset of the Menstrual Distress Questionnaire (MDQ) and included additional questions relating to appetite, well being and undesirable hair changes.

The study's primary objective was to evaluate intrasubject changes in premenstrual symptoms. Its secondary objective was to compare the effects of Yasmin on premenstrual symptoms in women newly using oral contraceptives (OCs) and those who switched from previous OCs.

Study Results
There were 258 women who completed the study. At the end of cycle six, premenstrual and menstrual symptom scores on the negative affect and water retention scales were reduced significantly compared to baseline (p<.001). Decrease in appetite during these same menstrual phases was also statistically significant (p=.001).

Similar improvements in premenstrual and menstrual symptom scores compared to baseline were reported among new OC users (p<.001) and those who switched from other OCs (p<.001).

Yasmin was well tolerated, and reported adverse events and discontinuation (6 percent) were typical of those associated with oral contraceptive use. The most frequently reported adverse events included headache (10.7 percent) and breast pain (9.2 percent). In addition, blood pressure, lipids, glucose tolerance, electrolytes and hematology values among Yasmin users all stayed within normal range.

Placebo-controlled comparative studies are needed in populations with more severe premenstrual symptoms using prospective diaries to confirm these findings.
-end-
This study was sponsored by Berlex Laboratories, Inc.

The UT Health Science Center is accredited by the Southern Association of Colleges and schools to award baccalaureate, master and doctoral degrees and currently offers seven undergraduate and 10 graduate/professional degrees within the Colleges of Allied Health Sciences, Dentistry, Graduate Health Sciences, Medicine, Nursing, Pharmacy, and the School of Biomedical Engineering. The campus has 43 endowed professorships of which 19 are Chairs of Excellence. The campus is home to seven Centers of Excellence. Founded in 1911, The University of Tennessee Health Science Center now includes the Graduate School of Medicine in Knoxville as well as graduate medical education programs in Knoxville, Chattanooga and Nashville; Family Medicine Centers in Knoxville, Jackson and Memphis; public and continuing education programs across the state; and the UT Bowld Hospital in Memphis. The UT Health Science Center is the ninth largest employer in Memphis with approximately 4,000 faculty and staff employees. The UT Medical Group, the private practice arm of the Health Science Center faculty, is the Mid-South's largest multi-specialty physician group practice. For more information visit www.utmem.edu.

Porter Novelli

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