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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar Pill | Placebo Comparator | Placebo Sugar Pill |
|
| Combined Oral Contraceptive Pill | Experimental | 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Oral Contraceptive Pill | Drug | 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maryam Guiahi, MD, MSc | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26181091 | Derived | 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. |
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Interested women were screened by phone and subsequently invited for a screening visit. At this visit they were assessed for eligibility based on the specified inclusion/exclusion criteria.
Women were invited to participate after being seen at one of our institution's clinics with the complaint of bothersome bleeding during use of etonogestrel implant, or after responding to advertisements posted on the internet, in the local newspaper, or around public venues. Women were enrolled and followed from November 2013 - December 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugar Pill | Placebo Sugar Pill Placebo Sugar Pill: Placebo Sugar Pill |
| FG001 | Combined Oral Contraceptive Pill | 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo Sugar Pill | Drug | Placebo Sugar Pill |
|
| Number of Days to Recurrence of Bleeding After Discontinuation of Therapy | Up to six months |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugar Pill | Placebo Sugar Pill Placebo Sugar Pill: Placebo Sugar Pill |
| BG001 | Combined Oral Contraceptive Pill | 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Total days of current bleeding episode | Mean | Standard Deviation | days |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of participants | At day 3 of 14 day course of study drug |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Days Until Temporary Interruption of Bleeding During Therapy Occurred | Posted | Median | Full Range | days | over the 14 day course of study drug |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Days Without Bleeding During Therapy | Posted | Median | Full Range | days | Over the 14 day course of study drug |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Days to Recurrence of Bleeding After Discontinuation of Therapy | Posted | Median | Full Range | days | Up to six months |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugar Pill | Placebo Sugar Pill Placebo Sugar Pill: Placebo Sugar Pill | 0 | 16 | 0 | 16 | ||
| EG001 | Combined Oral Contraceptive Pill | 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill | 0 | 16 | 0 | 16 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chanel Mansfield | University of Colorado Denver | 303-724-6501 | chanel.mansfield@ucdenver.edu |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003277 | Contraceptives, Oral, Combined |
| ID | Term |
|---|---|
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003276 | Contraceptives, Oral |
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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