A Study of Continuous Oral Contraceptives and Doxycycline
NCT ID: NCT00480532
Last Updated: 2014-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
131 participants
INTERVENTIONAL
2007-05-31
2011-05-31
Brief Summary
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Detailed Description
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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 controlled release subantimicrobial dose doxycycline (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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Doxycycline 100bid x5 days
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.
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.
Doxycycline 100bid x5 days at the time of bleeding
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
placebo bid x 5 days
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.
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
Subantimicrobial doxycycline daily
Oracea
40-mg tablet daily for 84 days
Subantimicrobial doxycycline daily
Subantimicrobial dose doxycycline 40mg daily for the first 84 days of the study
placebo daily
placebo daily
Placebo daily for the first 84 days of the study
Interventions
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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.
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.
Oracea
40-mg tablet daily for 84 days
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
Doxycycline 100bid x5 days at the time of bleeding
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
Subantimicrobial doxycycline daily
Subantimicrobial dose doxycycline 40mg daily for the first 84 days of the study
placebo daily
Placebo daily for the first 84 days of the study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to agree to randomization and sign informed consent
* Currently having regular menstrual cycles (24-36 days), with combined cyclic hormonal method (COCs, Nuva Ring, Ortho Evra), without intermenstrual bleeding in last 2 years.
Exclusion Criteria
* Abnormal pap smear that has not been treated or followed up
* Those with hypersensitivity reactions to doxycycline or any of the tetracyclines
* Use of depomedroxyprogesterone acetate within 9 months of the start of the study.
* Use of hormonal medications (excluding cyclic contraceptives and plan B) within 2 months of the start of the study.
* Any one unwilling to keep a daily menstrual diary or otherwise unwilling to follow the study criteria
* Currently taking medications that interfere with COCs (rifampin, carbamazepine, St. Johns wort)
* Currently has a progestin implant
* Positive Gonorrhea or Chlamydia cultures at enrollment examination
* Smoking more than 5 cigarettes per month
* Any medical condition that is a contraindication to the use of COCs in accordance with product labeling including:
* History of thrombophlebitis, deep venous thrombosis, thrombogenic vasculopathies, thrombogenic rhythm disorders or thromboembolic disorders
* Current or past history of cerebrovascular or coronary artery disease
* Scheduled major surgery in the next six months with prolonged immobilization
* Diabetes with vascular involvement
* Headache with focal neurologic symptoms
* Uncontrolled hypertension
* Suspected or known carcinoma of the breast or personal history of breast cancer
* Carcinoma of the endometrium or other known or suspected estrogen dependent neoplasms
* Undiagnosed genital bleeding
* History of cholestatic jaundice of pregnancy or cholestatic jaundice with prior oral contraceptive use
* Hepatic adenoma or carcinoma or active liver disease if liver function has not returned to normal
* Known or suspected pregnancy
* Hypersensitivity to estrogen or progesterone containing products
18 Years
45 Years
FEMALE
Yes
Sponsors
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Oregon Health and Science University
OTHER
Responsible Party
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Jeffrey Jensen
MD MPH
Principal Investigators
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Jeffrey T Jensen, M.D, MPH
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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University of Hawaii (UH)
Honolulu, Hawaii, United States
Oregon Health & Science University
Portland, Oregon, United States
Countries
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References
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Kaneshiro B, Edelman A, Carlson N, Morgan K, Nichols M, Jensen J. Treatment of unscheduled bleeding in continuous oral contraceptive users with doxycycline: a randomized controlled trial. Obstet Gynecol. 2010 Jun;115(6):1141-1149. doi: 10.1097/AOG.0b013e3181e0119c.
Kaneshiro B, Edelman A, Carlson NE, Nichols M, Forbes MM, Jensen J. A randomized controlled trial of subantimicrobial-dose doxycycline to prevent unscheduled bleeding with continuous oral contraceptive pill use. Contraception. 2012 Apr;85(4):351-8. doi: 10.1016/j.contraception.2011.08.006. Epub 2011 Sep 28.
Related Links
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Women's Health Research Unit website
Other Identifiers
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OHSU FAMPLAN 2907
Identifier Type: -
Identifier Source: org_study_id
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