A Study of Continuous Oral Contraceptives and Doxycycline

NCT00480532 | Completed Results

• 1 other identifier: OHSU FAMPLAN 2907
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Contraceptives, Oral

Keywords

birth control; continuous contraception; break-through bleeding

Outcome Measures

Primary Outcomes (1)

• Differences in Bleeding Patterns Between Study Groups.

  number of days of bleeding and spotting, self reported on calendar

  The outcome was also assessed for day 1 to 84

Secondary Outcomes (2)

• Subject Satisfaction.

  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

  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.

Study Arms (4)

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

Interventions

Lybrel DRUG

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.

Also known as: Lybrel (20-mcg Ethinyl Estradiol (EE)/90 mcg Levonorgestrel (LNG)

Doxycycline 100bid x5 days; placebo bid x 5 days

Doxycycline DRUG

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

Oracea DRUG

40-mg tablet daily for 84 days

Subantimicrobial doxycycline daily

Placebo DRUG

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

placebo bid x 5 days

Doxycycline 100bid x5 days at the time of bleeding 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

Doxycycline 100bid x5 days

Subantimicrobial doxycycline daily DRUG

Subantimicrobial dose doxycycline 40mg daily for the first 84 days of the study

Subantimicrobial doxycycline daily

placebo daily DRUG

Placebo daily for the first 84 days of the study

placebo daily

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (2)

University of Hawaii (UH)

Honolulu, Hawaii, 26826, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (2)

• 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.

  PMID: 20502283 RESULT

• 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.

  PMID: 22067758 RESULT

Related Links

• Women's Health Research Unit website

MeSH Terms

Conditions

Metrorrhagia

Interventions

lybrel; Ethinyl Estradiol; Doxycycline

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Treatment Arm: Subjects had difficulty understanding when to start and stop treatment.

Results Point of Contact

• Title: Bliss Kaneshiro
• Organization: University of Hawaii (UH)

bkaneshiro@ucera.org

808-203-6500

Study Officials

• Jeffrey T Jensen, M.D, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MPH

Study Record Dates

• First Submitted: May 30, 2007
• First Posted: May 31, 2007
• Study Start: May 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: May 1, 2011
• Last Updated: October 22, 2014
• Results First Posted: January 28, 2013

Record last verified: 2014-10

Locations

US (2)