Does Concomitant Use of Combined Oral Hormonal Steroids Stop Bleeding in Women Using Etonogestrel Implants (Implanon/Nexplanon®)?: A Randomized Controlled Study

NCT01968135 | Completed Phase 2 Results

• 1 other identifier: 13-1702
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aims are to determine if more women using Etonogestrel (ENG) contraceptive implants who report a bleeding-spotting episode of at least seven days will stop bleeding within 3 days of beginning a 14-day course of combined oral hormonal steroids, as compared to women receiving 14 days of placebo.

Conditions

Uterine Hemorrhage; Contraception

Outcome Measures

Primary Outcomes (1)

• Cessation of Vaginal Bleeding

  Proportion of women in each group who stopped bleeding during therapy and continued to report no bleeding at the end of the 14-day treatment period.

  At day 3 of 14 day course of study drug

Secondary Outcomes (3)

• Number of Days Until Temporary Interruption of Bleeding During Therapy Occurred

  over the 14 day course of study drug

• Number of Days Without Bleeding During Therapy

  Over the 14 day course of study drug

• Number of Days to Recurrence of Bleeding After Discontinuation of Therapy

  Up to six months

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Placebo Sugar Pill

Drug: Placebo Sugar Pill

Combined Oral Contraceptive Pill

EXPERIMENTAL

150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill

Drug: Combined Oral Contraceptive Pill

Interventions

Combined Oral Contraceptive Pill DRUG

150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill

Combined Oral Contraceptive Pill

Placebo Sugar Pill DRUG

Placebo Sugar Pill

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All female
• English or Spanish speaking women
• between the ages of 18-44
• using an ENG contraceptive implant who complain of bothersome bleeding and have a current bleeding episode of at least seven days will be invited to participate.

You may not qualify if:

• Category 3 or 4 contraindications to estrogen therapy according to the Centers for Disease Control 2010 Medical Eligibility Criteria.
• Category 3 contraindications: less than 1 month postpartum if breastfeeding, less than 21 days postpartum if not breastfeeding, history of Deep Vein Thrombosis (DVT) /Pulmonary Embolism (PE) not on anticoagulant therapy and no risk factors, Deep venous thrombosis/Pulmonary Embolus on established anticoagulant therapy and no risk factors, history of malabsorptive bariatric surgery, greater than or equal to months post peripartum cardiomyopathy with normal to mildly impaired cardiac function, greater than or equal to 35 years old with less than 15 cigarettes smoked per day, multiple risk factors for arterial cardiovascular disease, adequately controlled hypertension, blood pressure 140-159/90-99 mm Hg, migraines without aura less than 35 years old, past breast cancer and no evidence of recurrent disease for 5 years, diabetes with retinopathy, neuropathy, nephropathy (category 3 or 4 depending on severity), diabetes greater than 20 years duration or associated with other vascular disease, medically treated symptomatic gallbladder disease or current symptomatic gallbladder disease, past combined oral contraceptive pill related cholestasis, acute viral hepatitis, hepatocellular adenoma, hepatoma, use of ritonavir-boosted protease inhibitors, anticonvulsant therapy use including phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine, and lamotrigine, use of Rifampicin,
• Category 4 contraindications: less than 6 months post peripartum cardiomyopathy with normal to mildly impaired cardiac function, any time following peripartum cardiomyopathy with moderately to severely impaired cardiac function, greater than or equal to 35 years old with greater than 15 cigarettes smoked per day, multiple risk factors for arterial cardiovascular disease, blood pressure greater than or equal to 160/100 mm Hg, high risk for recurrent DVT/PE, acute DVT/PE, DVT/PE and on established anticoagulant therapy with greater than or equal to 1 risk factor for recurrent DVT/PE, major surgery/prolonged immobilization, known thrombogenic mutations, current and history of ischemic heart disease, history of stroke, complicated valvular heart disease, systemic lupus erythematosus (SLE) with positive or unknown antiphospholipid antibodies, migraines without aura greater than or equal to 35 years old, migraines with aura at any age, current breast cancer, complicated solid organ transplantation
• Body mass index (BMI) greater than 35.
• A systolic blood pressure greater than 135 on more than 2 occasions. assuring the measurements are separated by an interval of at least 15 minutes.
• A diastolic blood pressure greater than 85 on more than 2 occasions. assuring the measurement are separated by an interval of at least 15 minutes.
• A positive pregnancy test.
• A positive chlamydia test.
• Unable or unwilling to swallow pills.
• A medical condition deemed severed by a physician investigator.
• A participant taking a liver enzyme inducing drug.
• A known allergy to levonorgestrel or ethinyl estradiol.
• An abnormal speculum exam (i.e. bleeding ectropion or cervical mass).
• Does not meet appropriate cervical cytology screening guidelines.
• Cervical procedure done in the past 3 months.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Guiahi M, McBride M, Sheeder J, Teal S. Short-Term Treatment of Bothersome Bleeding for Etonogestrel Implant Users Using a 14-Day Oral Contraceptive Pill Regimen: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):508-513. doi: 10.1097/AOG.0000000000000974.

  PMID: 26181091 DERIVED

MeSH Terms

Conditions

Uterine Hemorrhage

Interventions

Contraceptives, Oral, Combined

Condition Hierarchy (Ancestors)

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)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Results Point of Contact

• Title: Chanel Mansfield
• Organization: University of Colorado Denver

chanel.mansfield@ucdenver.edu

303-724-6501

Study Officials

• Maryam Guiahi, MD, MSc

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 23, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 5, 2016
• Results First Posted: May 5, 2016

Record last verified: 2016-04

Locations

US (1)