Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350480
Status:
COMPLETED
Last Update Posted:
2015-03-11
First Post:
2006-07-06
Brief Title:
Treatment of Non-Gestational Acute Uterine Bleeding A Randomized Trial
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Treatment of Non-Gestational Acute Uterine BleedingComparing Oral Medroxyprogesterone Acetate and Monophasic Oral Contraceptives Containing Norethindrone and Ethinyl Estradiol
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the relative efficacy of multidose medroxyprogesterone acetate MPA Provera and a multidose monophasic combination oral contraceptive in the treatment of hemodynamically stable women with non-gestational acute uterine bleeding
Detailed Description:
Acute uterine bleeding unrelated to pregnancy is a relatively common problem that causes many reproductive-aged women to requite emergent medical andor surgical intervention Although the traditional approaches have generally been surgical in nature many practitioners utilize medical methods to arrest the bleeding However despite widespread use there exists a paucity of information regarding the effectiveness side-effects and patient satisfaction associated with the commonly-used medical regimens b The purpose of the study is to compare the efficacy of multidose medroxyprogesterone acetate and a multidose monophasic combined oral contraceptive in the treatment of hemodvnamically-stable women with non-gestational acute uterine bleeding
c Non-pregnant hemodynamically-stable reproductive-aged women over the age of IS who present either to the emergency area or to KP practitioners offices with acute uterine bleeding will be considered for eligibility If following a full exam and medically appropriate investigations medical management is deemed appropriate they will be approached by a member of the investigating team for possible inclusion into the study Following informed consent patients will be randomized to receive either medroxyprogesterone acetate 20 mg three times daily for 7 days or monophasic oral contraceptive containing I mg of norethindrone and 35 ug of ethinyl estradiol three dines daily for seven days Following the seven days of therapy those randomized to MPA will continue with 20 mg per day for three weeks while those randomized to oral contraceptives will take one pill per day for three weeks each completing a total of four weeks of therapy The primary outcome will be the number of days until cessation of bleeding Other outcomes measured will include pad and tampon counts and hemoglobin levels Chi square tests and student t will be used to evaluate differences between the two treatment groups The hope is that this study will elucidate on the efficacy of the two regimens
c Non-pregnant hemodynamically-stable reproductive-aged women over the age of IS who present either to the emergency area or to KP practitioners offices with acute uterine bleeding will be considered for eligibility If following a full exam and medically appropriate investigations medical management is deemed appropriate they will be approached by a member of the investigating team for possible inclusion into the study Following informed consent patients will be randomized to receive either medroxyprogesterone acetate 20 mg three times daily for 7 days or monophasic oral contraceptive containing I mg of norethindrone and 35 ug of ethinyl estradiol three dines daily for seven days Following the seven days of therapy those randomized to MPA will continue with 20 mg per day for three weeks while those randomized to oral contraceptives will take one pill per day for three weeks each completing a total of four weeks of therapy The primary outcome will be the number of days until cessation of bleeding Other outcomes measured will include pad and tampon counts and hemoglobin levels Chi square tests and student t will be used to evaluate differences between the two treatment groups The hope is that this study will elucidate on the efficacy of the two regimens
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None