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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01968135
First received: October 18, 2013
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

The investigators' specific aims are to determine if more women using 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.


Condition Intervention Phase
Uterine Hemorrhage
Contraception
Drug: Combined Oral Contraceptive Pill
Drug: Placebo Sugar Pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Does Concomitant Use of Combined Oral Hormonal Steroids Stop Bleeding in Women Using Etonogestrel Implants (Implanon/Nexplanon®)?: A Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Cessation of vaginal bleeding [ Time Frame: At day 3 of 14 day course of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of cessation of vaginal bleeding [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: October 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Pill
Placebo Sugar Pill
Drug: Placebo Sugar Pill
Placebo Sugar Pill
Experimental: Combined Oral Contraceptive Pill
150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Drug: Combined Oral Contraceptive Pill
150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill

Detailed Description:

The etonogestrel (ENG) contraceptive implant (Implanon/Nexplanon®), is a silicone- free, single rod subdermal contraceptive implant that contains 68 mg of etonogestrel, is approved for use for three years, and is one of the most effective forms of contraception available (1). ENG contraceptive implants are easily inserted and removed (1,2), offer quick return to fertility (2), are cost-effective and cost-saving (3,4) and offer non-contraceptive benefits such as improvement in pain for patients with complaints of dysmenorrhea (5).

Hypothesis: Women using ENG contraceptive implants who report a bleeding-spotting episode of at least seven days will be more likely to stop bleeding within 3 days of beginning a 14-day course of combined oral hormonal steroids compared to women receiving 14 days of placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • On a concurrent hormonal contraceptive and unwilling to discontinue.
  • Breast lesions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968135

Contacts
Contact: Maryke Swartz, MS 303-724-8482 maryke.swartz@ucdenver.edu
Contact: Sandra Cano, MA 303-724-2013 sandra.cano@ucdenver.edu

Locations
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Maryke Swartz, MS    303-724-8482    maryke.swartz@ucdenver.edu   
Principal Investigator: Maryam Guiahi, MD, MSc         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Maryam Guiahi, MD, MSc University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01968135     History of Changes
Other Study ID Numbers: 13-1702
Study First Received: October 18, 2013
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Uterine Hemorrhage
Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Contraceptives, Oral
Contraceptive Agents
Contraceptives, Oral, Combined
Contraceptive Agents, Female
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014