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

University of California (UC) Davis

Status and phase: Terminated; Phase 4

Conditions: Abnormal Uterine Bleeding, Unspecified; Uterine Bleeding Heavy

Treatments: Drug: Placebo; Drug: EE 30mcg/LNG 150mcg

Study type: Interventional

Funder types: Other

Identifiers

NCT01963403

478388

MISP 50618 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

Women who are experiencing irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant will be recruited for this study. Women who have bothersome bleeding will be randomized to use either a combined oral contraceptive pill or a placebo pill.

Participants will take one pill every day and record their bleeding patterns on a daily diary.

Participants will have one screening/enrollment visit, two in-person follow up visits, and one telephone follow up contact. Subjects will be enrolled for a total of 84 days (three months).

Participants will be assigned to a treatment group at her screening/enrollment visit. Her first follow up visit will occur 22-28 days after her enrollment. Participants can choose to:

• Continue use of assigned treatment medication
• Discontinue use of assigned treatment medication, but use an open-label combined oral contraceptive pill
• Discontinue the use of assigned treatment medication, decline use of an open-label combined oral contraceptive pill
• Discontinue use of ETG implant.

Participants who choose to continue use of ETG implant will have a follow up telephone contact 50-56 days after her enrollment visit. A final in-person visit will occur 78-84 days after enrollment. Bleeding patterns will be assessed by daily bleeding diaries completed by the participant.

Enrollment: 26 patients

Sex: Female

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups, including a placebo group

EE 30mcg/LNG 150mcg

Active Comparator group

Description:

combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)

Treatment:

Drug: EE 30mcg/LNG 150mcg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo