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

NCT01963403 | Terminated Phase 4 Results

• 2 other identifiers: 478388MISP 50618
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Abnormal Uterine Bleeding, Unspecified; Uterine Bleeding Heavy

Keywords

etonogestrel implant; birth control; irregular bleeding; heavy bleeding

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Bleeding Improvement

  Bleeding improvement will be measured by participant response to the question of whether she feels her bleeding is improved and she is satisfied with the treatment.

  Bleeding improvement will be evaluated during first cycle of study treatment (28 days)

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  Adverse events will be evaluated at each contact (visits at 1 and 3 months, phone contact at 2 months) with the participant

Other Outcomes (2)

• Number of Participants withTreatment Success or Failure

  Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months

• Bleeding Patterns and Number of Participants With Bleeding Improvement

  Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months

Study Arms (2)

EE 30mcg/LNG 150mcg

ACTIVE COMPARATOR

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

Drug: EE 30mcg/LNG 150mcg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

EE 30mcg/LNG 150mcg DRUG

1 pill per day; daily during study participation (up to 84 days)

Also known as: Levlen28, Levora, Portia 28, Altavera

EE 30mcg/LNG 150mcg

Placebo DRUG

1 pill per day; daily during study participation (up to 84 days)

Placebo

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• years of age and older and smoking
• Multiple risk factors for arterial cardiovascular disease

Sponsors & Collaborators

• University of California, Davis: lead
• Washington University School of Medicine: collaborator

Study Sites (2)

University of California, Davis Department of Obstetrics and Gynecology

Sacramento, California, 95817, United States

Location

Washington University School of Medicine, Department of Obstetrics and Gynecology

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Hou MY, McNicholas C, Creinin MD. Combined oral contraceptive treatment for bleeding complaints with the etonogestrel contraceptive implant: a randomised controlled trial. Eur J Contracept Reprod Health Care. 2016 Oct;21(5):361-6. doi: 10.1080/13625187.2016.1210122. Epub 2016 Jul 15.

  PMID: 27419258 RESULT

MeSH Terms

Conditions

Metrorrhagia

Interventions

Ethinyl Estradiol-Norgestrel Combination

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)

Ethinyl Estradiol; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norgestrel; Norpregnenes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Mitchell Creinin
• Organization: UC Davis

mdcreinin@ucdavis.edu

916-734-6670

Study Officials

• Mitchell Creinin, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Melody Hou, MD

  University of California, Davis

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Family Planning

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 16, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 12, 2017
• Results First Posted: May 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)