Uterine HemorrhagePhase 2NCT01968135
Does Concomitant Use of Combined Oral Hormonal Steroids Stop Bleeding in Women Using Etonogestrel Implants (Implanon/Nexplanon®)?: A Randomized Controlled Study
A Phase 2 study testing Combined Oral Contraceptive Pill in people with Uterine Hemorrhage and Contraception, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Hemorrhage, Contraception
- What is being tested?
- Combined Oral Contraceptive Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Nov 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The 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.
- Conditions
- Uterine Hemorrhage, Contraception
- Being tested
- Combined Oral Contraceptive Pill, Placebo Sugar Pill
- Medical subject headings
- Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Oral Contraceptive PillDrug
150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Placebo Sugar PillDrug
Placebo Sugar Pill
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Placebo Sugar Pill Receives: Drug: Placebo Sugar Pill |
| Combined Oral Contraceptive Pill | Experimental | 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill Receives: Drug: Combined Oral Contraceptive Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At day 3 of 14 day course of study drug
Secondary outcomes (3)
Number of Days Until Temporary Interruption of Bleeding During Therapy Occurred
Measured: over the 14 day course of study drug
Number of Days Without Bleeding During Therapy
Measured: Over the 14 day course of study drug
Number of Days to Recurrence of Bleeding After Discontinuation of Therapy
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine HemorrhageStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Guiahi, MD, MSc, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968135
- Sponsor's protocol ID
- 13-1702
- Status last verified
- Apr 2016
- First submitted
- 18 Oct 2013
- Last updated
- 5 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26181091
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Concomitant Use of Combined Oral Hormonal Steroids Stop Bleeding in Women Using Etonogestrel Implants (Implanon/Nexplanon®)?: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01968135
- Acronym / sponsor ID
- 13-1702
- Conditions
- Uterine Hemorrhage, Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Oct 2013 (estimated)
- Results
- Posted 5 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Drug: Placebo Sugar PillPlacebo Sugar Pill |
| Combined Oral Contraceptive Pill | Experimental | Drug: Combined Oral Contraceptive Pill150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Oral Contraceptive Pill150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill | Drug | Combined Oral Contraceptive Pill |
| Placebo Sugar PillPlacebo Sugar Pill | Drug | Sugar Pill |
Primary outcome
Cessation of Vaginal Bleeding
Time frame: At day 3 of 14 day course of study drug
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.
3 secondary outcomes
Number of Days Until Temporary Interruption of Bleeding During Therapy Occurred
Time frame: over the 14 day course of study drug
Number of Days Without Bleeding During Therapy
Time frame: Over the 14 day course of study drug
Number of Days to Recurrence of Bleeding After Discontinuation of Therapy
Time frame: Up to six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26181091Guiahi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam Guiahi, MD, MSc principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combined Oral Contraceptive Pill in people with Uterine Hemorrhage and Contraception, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cessation of Vaginal Bleeding (time frame: At day 3 of 14 day course of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01968135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.