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Sponsors and Collaborators: |
Scott and White Hospital & Clinic Warner Chilcott |
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Information provided by: | Scott and White Hospital & Clinic |
ClinicalTrials.gov Identifier: | NCT00475189 |
The purpose of this research study is to assess hormone withdrawal symptoms in women while taking an oral contraceptive in the novel 24/4 (24 days of "real" pills) manner in comparison to taking pills in the standard 21/7 (21 "real" pills) manner.
It is hypothesized that the 24/4 method will reduce common hormone withdrawal symptoms compared to the standard 21/7 regimen.
It is further hypothesized that women using the 24/4 regimen will report greater satisfaction scores.
Condition | Intervention |
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Pelvic Pain Headaches Emotional |
Drug: loestrin 24/4 vs loestrin 1/20 Drug: loestrin 1/20 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Efficacy Study |
Official Title: | Prospective Comparison of Hormone Withdrawal Symptoms of a 24/4 Regimen With a 21/7 Regimen of OC |
Enrollment: | 51 |
Study Start Date: | June 2007 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: loestrin 24/4 vs loestrin 1/20
One month of loestrin 1/20 then randomized to Loestrin 24/4 or Loestrin 1/20 x 3 months. After 3 months if randomized to 1/20 will be switched to 24/4 if already on 24/4 will be given a choice which OC they want to continue for 3 more months.
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II: Active Comparator
loestrin 1/20 given 1 tab 21/7
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Drug: loestrin 1/20
loestrin 1/20 1 tab 21/7 x 3mo and then changed to Loestrin 24 FE
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Ages Eligible for Study: | 18 Years to 48 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Scott & White Hospital and Clinic | |
Temple, Texas, United States, 76508 |
Principal Investigator: | Patricia Sulak, MD | Scott and White Hospital and Clinic |
Responsible Party: | Scott and White Hospital ( Dr. Patricia Sulak ) |
Study ID Numbers: | 60783 |
Study First Received: | May 16, 2007 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00475189 History of Changes |
Health Authority: | United States: Institutional Review Board |
birth control PMS headaches mood swings pelvic pain |
Modicon Contraceptive Agents Contraceptives, Oral Contraceptive Agents, Female Pain Norinyl Hormones |
Contraceptives, Oral, Combined Signs and Symptoms Contraceptives, Oral, Sequential Pelvic Pain Contraceptives, Oral, Hormonal Headache Neurologic Manifestations |
Modicon Contraceptive Agents Physiological Effects of Drugs Nervous System Diseases Contraceptives, Oral Contraceptive Agents, Female Pain Reproductive Control Agents Norinyl Pharmacologic Actions |
Contraceptives, Oral, Combined Contraceptives, Oral, Sequential Signs and Symptoms Pelvic Pain Contraceptives, Oral, Hormonal Therapeutic Uses Headache Contraceptives, Oral, Synthetic Neurologic Manifestations |