Abnormal Uterine Bleeding, Unspecified Clinical Trial
— ROBIOfficial title:
Relief of Bleeding on the Implant: Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With a Combined Oral Contraceptive: A Placebo-Controlled Randomized Trial
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
| Status | Terminated |
| Enrollment | 26 |
| Est. completion date | September 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 14 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 35 years of age and older and smoking - Multiple risk factors for arterial cardiovascular disease - Systemic Lupus Erythematosus with positive or unknown antiphospholipid antibodies - Current symptomatic gallbladder disease or history of cholestasis related to past combined oral contraceptive use - On certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine, lamotrigine) - On Ritonavir-boosted protease inhibitors for antiretroviral therapy - Issues or concerns, in the judgment of the investigator, that may compromise the safety of the subject, impact the subject's adherence to the protocol requirements, or confound the reliability of the data acquired in this study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of California, Davis Department of Obstetrics and Gynecology | Sacramento | California |
| United States | Washington University School of Medicine, Department of Obstetrics and Gynecology | St. Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Davis | Washington University School of Medicine |
United States,
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: 10.1080/13625187.20 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Treatment Success or Failure | Treatment success will be measured by desire to continue treatment because the initial treatment made the bleeding better. Partial failure of the study treatment will be measured by the desire to continue treatment because the initial treatment did not work Complete failure of treatment will be measured by the desire to: discontinue treatment because it did not work; no further treatment requested ETG implant removal Desire to use non-study treatment |
Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months | No |
| Other | Bleeding patterns | Bleeding improvement in women who received placebo but opted for open-label treatment after first cycle Bleeding improvement over the 84 days of study participation Bleeding patterns in placebo vs. combined oral contraceptive users |
Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months | No |
| Primary | 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) | No |
| Secondary | Adverse Events | Participants will be evaluated for adverse events while using a combined oral contraceptive with ETG implant. | Adverse events will be evaluated at each contact (visits at 1 and 3 months, phone contact at 2 months) with the participant | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02059954 -
Vaginal vs. Laparoscopic Hysterectomy
|
N/A | |
| Recruiting |
NCT01929148 -
Prophylactic Bilateral Salpingectomy and Laparoscopic Myomectomy
|
N/A |