OBJECTIVES: The purpose of this study is to determine if the use of a specific prostaglandin endoperoxide-2 inhibitor will prevent luteal development in women. STUDY DESIGN:Ovulatory reproductive-aged women not using or needing hormonal contraception were prospectively followed for three menstrual cycles. Women were randomized into two groups using a crossover design [Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally) cycle; Group 2: control cycle, celecoxib cycle, placebo cycle]. Study drug was dosed daily until the onset of the next menses. Demographics, menstrual cycle length and twice-weekly progesterone (P) levels during the placebo and active drug cycles were recorded. End points included the change in luteal phase P levels and menstrual cycle length (days) during active drug exposure. RESULTS: A total of 11 women completed the study (Group 1, n=7; Group 2, n=4). No demographic differences were found between groups [age, race, body mass index (BMI), control cycle length]. A comparison of the control and active drug cycles for all participants demonstrated a trend toward a longer menstrual cycle with active drug exposure [control, 27.2 days (SD, 2.4); study drug, 28.5 days (SD, 2.5), p=.09]. Five women had a delay in the rise of their luteal phase P levels, two women had lower peak P levels and two women had no elevation of luteal phase P levels during active drug cycle as compared to placebo cycle. CONCLUSION: Daily administration of a prostaglandin synthesis inhibitor may delay the timing of luteal events and, therefore, fertility in women. PTGS2 inhibitors may hold potential as an emergency contraceptive.
RCT Entities:
OBJECTIVES: The purpose of this study is to determine if the use of a specific prostaglandin endoperoxide-2 inhibitor will prevent luteal development in women. STUDY DESIGN: Ovulatory reproductive-aged women not using or needing hormonal contraception were prospectively followed for three menstrual cycles. Women were randomized into two groups using a crossover design [Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally) cycle; Group 2: control cycle, celecoxib cycle, placebo cycle]. Study drug was dosed daily until the onset of the next menses. Demographics, menstrual cycle length and twice-weekly progesterone (P) levels during the placebo and active drug cycles were recorded. End points included the change in luteal phase P levels and menstrual cycle length (days) during active drug exposure. RESULTS: A total of 11 women completed the study (Group 1, n=7; Group 2, n=4). No demographic differences were found between groups [age, race, body mass index (BMI), control cycle length]. A comparison of the control and active drug cycles for all participants demonstrated a trend toward a longer menstrual cycle with active drug exposure [control, 27.2 days (SD, 2.4); study drug, 28.5 days (SD, 2.5), p=.09]. Five women had a delay in the rise of their luteal phase P levels, two women had lower peak P levels and two women had no elevation of luteal phase P levels during active drug cycle as compared to placebo cycle. CONCLUSION: Daily administration of a prostaglandin synthesis inhibitor may delay the timing of luteal events and, therefore, fertility in women. PTGS2 inhibitors may hold potential as an emergency contraceptive.
Authors: M R Massai; M L Forcelledo; V Brache; A S Tejada; A M Salvatierra; M V Reyes; F Alvarez; A Faúndes; H B Croxatto Journal: Hum Reprod Date: 2006-09-15 Impact factor: 6.918
Authors: Min Yan; Seung-Jae Myung; Stephen P Fink; Earl Lawrence; James Lutterbaugh; Peiying Yang; Xiaohua Zhou; Danielle Liu; Ronald M Rerko; Joseph Willis; Dawn Dawson; Hsin-Hsiung Tai; Jill S Barnholtz-Sloan; Robert A Newman; Monica M Bertagnolli; Sanford D Markowitz Journal: Proc Natl Acad Sci U S A Date: 2009-05-22 Impact factor: 11.205