Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Oregon Health and Science University OHSU Family Planning Fellowship Foundation Wyeth |
---|---|
Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00480532 |
The purpose of this study is to learn if the study drug, doxycycline, can decrease the amount of unplanned vaginal bleeding that women commonly experience when taking combined oral contraception (pills with estrogen and progestin) in a continuous fashion (no hormone-free week). The study drug, doxycycline, is an antibiotic used commonly for many conditions (i.e. acne, Chlamydia infections, pneumonia) and can be safely used on a daily basis. Doxycycline has been shown to decrease unplanned vaginal bleeding in progestin-only contraception but has not been studied in combined hormonal contraception.
Condition | Intervention |
---|---|
Menstrual Bleeding |
Drug: Lybrel Drug: Doxycycline Drug: Oracea Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | A Study of Continuous Oral Contraceptives and Doxycycline |
Estimated Enrollment: | 200 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Lybrel
All women enrolled in the study will take the same daily low dose oral contraceptive (20-mcg EE/90 mcg LNG) dosed in a continuous fashion.
Drug: Doxycycline
100 mg orally twice a day for five days starting on the first day of breakthrough bleeding. This regimen will be repeated if bleeding persists or recurs seven days after completing five-day course of doxycycline.
|
2: Placebo Comparator |
Drug: Lybrel
All women enrolled in the study will take the same daily low dose oral contraceptive (20-mcg EE/90 mcg LNG) dosed in a continuous fashion.
Drug: Placebo
Placebo pill orally twice a day for five days starting on the first day of breakthrough bleeding. This regimen will be repeated if bleeding persists or recurs seven days after completing five-day course of placebo
|
3: Experimental |
Drug: Lybrel
All women enrolled in the study will take the same daily low dose oral contraceptive (20-mcg EE/90 mcg LNG) dosed in a continuous fashion.
Drug: Oracea
40-mg tablet daily for 84 days
|
4: Placebo Comparator |
Drug: Lybrel
All women enrolled in the study will take the same daily low dose oral contraceptive (20-mcg EE/90 mcg LNG) dosed in a continuous fashion.
Drug: Placebo
Placebo pill orally twice a day for five days starting on the first day of breakthrough bleeding. This regimen will be repeated if bleeding persists or recurs seven days after completing five-day course of placebo
|
We intend to conduct a prospective, randomized, placebo controlled, double blind study at Oregon Health and Science University. This study will be conducted over four 28-day cycles (112 days of active COC hormone). All women enrolled in the study will take the same daily low dose COC. This protocol will be divided into two studies, a bleeding study and an endometrial biopsy study, each with two treatment arms; typical dose doxycycline (Arm 1), and CRSD (Arm 2).
The first arm (Arm 1) of this study will constitute the typical dose doxycycline arm. In this arm, there will be two study groups. Group 1, the treatment group, will take doxycycline 100 mg orally twice a day for five days starting on the first day of bleeding if breakthrough bleeding occurs. The control group will take a placebo orally twice a day for five days starting on the first day of bleeding if breakthrough bleeding occurs. After three months, both groups will stop doxycycline (or placebo) and will continue on a COC alone for the remaining 28 days of the study.
The second arm (Arm 2) of the study will constitute the CRSD doxycycline arm. Subjects in this arm of the study will be divided into Group 3 and Group 4. Group 3 will take CRSD doxycycline (40mg) daily for three months. Group 4 will take a daily placebo. Similarly to the first arm of the trial, after three months, both groups will stop doxycycline (or placebo) and will continue in a COC alone for the remaining 28 days of the study.
This study also includes a endometrial biopsy sub-study: At the time of recruitment we will identify participants who are willing to undergo endometrial biopsy during the study period. These subjects will constitute a separate cohort who will enroll in the prospective, randomized, double blind, placebo controlled endometrial biopsy study.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Any medical condition that is a contraindication to the use of COCs in accordance with product labeling including:
Contact: Women's Health Research Unit Confidential Recruitment Line | 503 494-3666 | whru@ohsu.edu |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Jennifer Rhodes 503-494-0585 rhodesje@ohsu.edu | |
Principal Investigator: Jeffrey T Jensen, M.D., MPH | |
Sub-Investigator: Alison Edelman, M.D., MPH | |
Sub-Investigator: Mark Nichols, M.D. | |
Sub-Investigator: Paula Bednarek, M.D. | |
Sub-Investigator: Bliss Kaneshiro, M.D. | |
Sub-Investigator: Marcella Messerle Forbes, FNP | |
Sub-Investigator: Andrea O'Donnell, FNP |
Principal Investigator: | Jeffrey T Jensen, M.D, MPH | Oregon Health and Science University |
Responsible Party: | OHSU ( Jeffrey Jensen ) |
Study ID Numbers: | OHSU FAMPLAN 2907 |
Study First Received: | May 30, 2007 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00480532 |
Health Authority: | United States: Food and Drug Administration |
birth control continuous contraception break-through bleeding |
Metrorrhagia Hemorrhage Doxycycline |
Antimalarials Anti-Infective Agents Anti-Bacterial Agents Antiparasitic Agents |
Antiprotozoal Agents Therapeutic Uses Pharmacologic Actions |