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

Information source: University of California, Davis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Abnormal Uterine Bleeding, Unspecified; Uterine Bleeding Heavy

Intervention: EE 30mcg/LNG 150mcg (Drug); Placebo (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: University of California, Davis

Official(s) and/or principal investigator(s):
Mitchell Creinin, MD, Principal Investigator, Affiliation: University of California, Davis
Melody Hou, MD, Study Director, Affiliation: University of California, Davis

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

Clinical Details

Official title: Relief of Bleeding on the Implant: Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With a Combined Oral Contraceptive: A Placebo-Controlled Randomized Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Bleeding Improvement

Secondary outcome: Adverse Events

Detailed 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.

Eligibility

Minimum age: 14 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

University of California, Davis Department of Obstetrics and Gynecology, Sacramento, California 95817, United States

Washington University School of Medicine, Department of Obstetrics and Gynecology, St. Louis, Missouri 63110, United States

Additional Information

Starting date: December 2013
Last updated: June 2, 2015

Page last updated: August 23, 2015

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