Contraceptives, OralNCT00480532
A Study of Continuous Oral Contraceptives and Doxycycline
A study testing Lybrel, Doxycycline and Oracea in people with Contraceptives, Oral, run by Oregon Health and Science University at 2 sites in United States.
Trial summary
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 (COC)- pills with estrogen and progestin - in a continuous fashion - no hormone-free week. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptives, Oral
- What is being tested?
- Lybrel, Doxycycline and Oracea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- General good health
- 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.
Who cannot join
- Intrauterine device (IUD) in place
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Hawaii (UH)
Honolulu, Hawaii, 26826
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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 (COC)- 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.
Read the detailed description
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 controlled release subantimicrobial dose doxycycline (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 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
- Contraceptives, Oral
- Being tested
- Lybrel, Doxycycline, Oracea, Placebo, Doxycycline 100bid x5 days at the time of bleeding
- Keywords
- birth control, continuous contraception, break-through bleeding
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LybrelDrug
Also called Lybrel (20-mcg Ethinyl Estradiol (EE)/90 mcg Levonorgestrel (LNG)
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.
DoxycyclineDrug
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.
OraceaDrug
40-mg tablet daily for 84 days
PlaceboDrug
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 bleedingDrug
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 dailyDrug
Subantimicrobial dose doxycycline 40mg daily for the first 84 days of the study
placebo dailyDrug
Placebo daily for the first 84 days of the study
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline 100bid x5 days | Experimental | Not described Receives: Drug: Lybrel; Drug: Doxycycline; Drug: Doxycycline 100bid x5 days at the time of bleeding |
| placebo bid x 5 days | Placebo comparator | Not described Receives: Drug: Lybrel; Drug: Placebo |
| Subantimicrobial doxycycline daily | Experimental | Not described Receives: Drug: Oracea; Drug: Subantimicrobial doxycycline daily |
| placebo daily | Placebo comparator | Not described Receives: Drug: placebo daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Bleeding Patterns Between Study Groups.
number of days of bleeding and spotting, self reported on calendar
Measured: The outcome was also assessed for day 1 to 84
Secondary outcomes (2)
Subject Satisfaction.
measured using 100 mm visual analog scale. anchors of "not at all satisfied" (0mm) "extremely satisfied" (100mm)
Measured: Assessed on day 112 of the study (the end of the study period). This outcome does not represent a change from baseline. It was assessed at the end of the study period.
Subject Compliance
measured by self report of pill intake on daily diary (yes/no), and reported as percentage with no missed pills over entire study
Measured: Assessed on day 112 of the study (the end of the study period). The outcome reflects the number of subjects who did not miss pills during the entire 112 day study. It does not represent a change from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Contraceptives, OralStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Jensen, Oregon Health and Science University
- Investigators
- Jeffrey T Jensen, M.D, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480532
- Sponsor's protocol ID
- OHSU FAMPLAN 2907
- Status last verified
- Oct 2014
- First submitted
- 30 May 2007
- Last updated
- 22 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20502283Kaneshiro 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.
PubMed 22067758
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Continuous Oral Contraceptives and Doxycycline
- ClinicalTrials.gov ID
- NCT00480532
- Acronym / sponsor ID
- OHSU FAMPLAN 2907
- Conditions
- Contraceptives, Oral
- Keywords
- birth control, continuous contraception, break-through bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 31 May 2007 (estimated)
- Results
- Posted 28 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (COC)- 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.
Detailed description
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 controlled release subantimicrobial dose doxycycline (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Doxycycline 100bid x5 days | Experimental | Drug: Lybrel, Drug: Doxycycline, Drug: Doxycycline 100bid x5 days at the time of bleeding |
| placebo bid x 5 days | Placebo comparator | Drug: Lybrel, Drug: Placebo |
| Subantimicrobial doxycycline daily | Experimental | Drug: Oracea, Drug: Subantimicrobial doxycycline daily |
| placebo daily | Placebo comparator | Drug: placebo daily |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- General good health
- 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.
Key exclusion criteria (24 listed)
- Intrauterine device (IUD) in place
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LybrelAlso: Lybrel (20-mcg Ethinyl Estradiol (EE)/90 mcg Levonorgestrel (LNG)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 100bid x5 days, placebo bid x 5 days |
| Doxycycline100 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. | Drug | Doxycycline 100bid x5 days |
| Oracea40-mg tablet daily for 84 days | Drug | Subantimicrobial doxycycline daily |
| PlaceboPlacebo 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 | Drug | placebo bid x 5 days |
| Doxycycline 100bid x5 days at the time of bleedingDoxycycline 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 | Drug | Doxycycline 100bid x5 days |
| Subantimicrobial doxycycline dailySubantimicrobial dose doxycycline 40mg daily for the first 84 days of the study | Drug | Subantimicrobial doxycycline daily |
| placebo dailyPlacebo daily for the first 84 days of the study | Drug | placebo daily |
Primary outcome
Differences in Bleeding Patterns Between Study Groups.
Time frame: The outcome was also assessed for day 1 to 84
number of days of bleeding and spotting, self reported on calendar
2 secondary outcomes
Subject Satisfaction.
Time frame: Assessed on day 112 of the study (the end of the study period). This outcome does not represent a change from baseline. It was assessed at the end of the study period.
Subject Compliance
Time frame: Assessed on day 112 of the study (the end of the study period). The outcome reflects the number of subjects who did not miss pills during the entire 112 day study. It does not represent a change from baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20502283Kaneshiro 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.
- Results publication: PubMed 22067758Kaneshiro 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.
- Women's Health Research Unit websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey T Jensen, M.D, MPH principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lybrel, Doxycycline and Oracea in people with Contraceptives, Oral, run by Oregon Health and Science University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Bleeding Patterns Between Study Groups. (time frame: The outcome was also assessed for day 1 to 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00480532, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2014.