Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

This double-blinded, placebo-controlled, randomized trial will compare the effects of the use of a combined oral contraceptive pill to a placebo pill for women who are experiencing irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant.

The hypothesis of the study is:

• Use of combined oral contraceptive will significantly improve bleeding patterns for users of ETG implant

• Continuation rate of ETG implant users will be increased by use of combined oral contraceptive in women desiring ETG implant removal because of the undesirable bleeding

• Adverse events will be uncommon and acceptable to women who use a combined oral contraceptive with the ETG implant

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Collaborator: Washington University School of Medicine
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined

Criteria

Inclusion Criteria:

• Women who have an ETG implant in place

• Women who subjectively experience the side effect of an undesirable bleeding profile such as bleeding irregularity or heavy flow after ETG implant was placed and who desire intervention for this side effect by either treatment of bleeding or removal of the implant

• Age 14 years an older, inclusive

Exclusion Criteria:

• Irregular or heavy bleeding from an etiology other than ETG use (e.g. fibroids, cervical polyp, or other organic cause of bleeding)

• Has attempted prescription treatment for menstrual side effects while using ETG implant

• Has one or more of the conditions considered Category 3 (risks outweigh benefits) or Category 4 (unacceptable health risk) for estrogen-containing oral contraceptives by the Center for Disease Control Medical Eligibility Criteria for Contraceptive Use:

• Current or history of heart or vascular diseases, including deep venous thrombosis, pulmonary embolism, known thrombogenic mutations, peripartum cardiomyopathy, and complicated valvular heart disease

• Hypertension, even if adequately controlled

• Diabetes with vascular involvement

• Headaches with focal aura, or migraines in women age 35 and older even without focal aura

• Major surgery with prolonged immobilization

• Breast cancer (current or past)

• Severe (decompensated) cirrhosis

• Acute or flare viral hepatitis

• Breastfeeding less than 1 month postpartum

• Post-partum less than 3 weeks

• 35 years of age and older and smoking

• Multiple risk factors for arterial cardiovascular disease

• Systemic Lupus Erythematosus with positive or unknown antiphospholipid antibodies

• Current symptomatic gallbladder disease or history of cholestasis related to past combined oral contraceptive use

• On certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine, lamotrigine)

• On Ritonavir-boosted protease inhibitors for antiretroviral therapy

• Issues or concerns, in the judgment of the investigator, that may compromise the safety of the subject, impact the subject's adherence to the protocol requirements, or confound the reliability of the data acquired in this study