Management of Etonogestrel Subdermal Implant-related Bleeding
This is a double-blinded, randomized, prospective placebo-controlled clinical trial to be conducted within the Mayo Clinic and the Mayo Clinic Health System.
The goal of the research study is to gather information to determine whether Doxycycline is effective for the treatment of unacceptable bleeding associated with the etonogestrel subdermal implant (ESI), as compared to placebo.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Management of Etonogestrel Subdermal Implant-related Bleeding in US Women: a Prospective, Randomized, Placebo-controlled Trial.|
- Efficacy and safety of Doxycycline compared to placebo for unacceptable bleeding [ Time Frame: 13 weeks post-randomization ] [ Designated as safety issue: Yes ]
The efficacy of Doxycycline on ESI-related bleeding will be compared to placebo based on rates of unacceptable bleeding and weekly prospective symptom diary at 13 weeks post-randomization.
Method continuation rate at 13 weeks post-randomization will be compared.
Bleeding patterns will be quantified based on the PBLAC and WHO classification of clinically important bleeding patterns over each 13 week reference period.
Incidence of additional symptoms including acne, headache, mood changes in the treatment groups will be compared to placebo at randomization and 13 weeks post-randomization based on the weekly prospective symptom diary.
Interval to recurrence of unacceptable bleeding post-randomized treatment will be calculated.
Rate of adverse events associated with medical treatment will be documented by prospective symptom diary and BMI calculation. These include headache, mood changes, acne and change in BMI.
- Patient Satisfaction [ Time Frame: Change from randomization to 13 weeks post-treatment ] [ Designated as safety issue: No ]
Patient satisfaction with ESI will be assessed at randomization (pre-treatment)and will be compared to patient satisfaction assessed at 13 weeks following primary treatment with Doxycycline / placebo.
For patients receiving secondary treatment with Doxycycline, satisfaction with ESI will be assessed again at 26 weeks post-randomized treatment.
- Method Continuation rate [ Time Frame: 26 weeks post-randomization ] [ Designated as safety issue: No ]
Method continuation rate at 26 weeks post-randomized treatment for patients with continued unacceptable bleeding after primary treatment who undergo secondary treatment with Doxycycline will be calculated Rate of ESI removal for bleeding between 13 and 26 weeks post randomization. Rate of ESI removal for reasons other than bleeding with enumeration of reasons for removal between 13 and 26 weeks post-randomization.
Alternative contraception chosen in the event of ESI removal will be documented.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Doxycycline
Doxycycline 100 mg oral capsules, twice daily for 10 days
Doxycycline 100 mg oral capsules twice daily for 10 days
Other Name: Adoxa, Alodox, Avidoxy, Bio-Tab, Doryx, Doxy Lemmon, Doxy-Caps, Monodox, Morgidox, Ocudox, Oracea, Oraxyl, Periostat, Vibra-Tabs, Vibramycin
Placebo Comparator: Placebo
Placebo capsules, identical to oral Doxycycline 100 mg, twice daily for 10 days.
Placebo, one capsule orally twice daily for 10 days
Other Name: Sugar pill
ESI is a long-acting reversible contraceptive. Though safety and efficacy have been established world wide, only about 1 % of women have been reported to use this method. Its use is limited by bleeding pattern changes which result in requests for early removal, most commonly within the first 8 months of use.
Women ages 18-51 years, choosing ESI and who meet eligibility criteria, will be offered enrollment in the study at the time of ESI insertion. Every effort will be made to insert Implanon on the same day as consent unless medically contraindicated. Prospective diaries will be completed starting on the date of ESI insertion. All participants will be contacted by study personnel 13 weeks after enrollment and queried as to the presence of unacceptable bleeding. Bleeding concerns will be objectively assessed using a modification of the Pictorial Blood Loss Assessment Chart (PBLAC).
Participants initiating contact with bleeding concerns at any time after 13 weeks post-ESI insertion will be offered treatment randomization at the time of contact. The basis for randomized treatment will be whether the bleeding is considered "unacceptable" to the participant. This is inherently subjective, but constitutes the basis for most removal requests. Participants that report unacceptable bleeding at 13 weeks post-ESI insertion, and those who call with bleeding concerns anytime after 13 weeks post-ESI insertion, will be randomized into one of two groups, Doxycycline or matching placebo.
Participants that do not report unacceptable bleeding will continue to complete diaries and may be eligible for randomized treatment if unacceptable bleeding develops.
|Contact: Kristi L Allen, BSN, RNfirstname.lastname@example.org|
|Contact: Maureen A Lemens, BSN, RNemail@example.com|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Kristi L Allen, BSN, RN 507-293-3446 firstname.lastname@example.org|
|Contact: Maureen A Lemens, BSN, RN 507-293-1487 email@example.com|
|Principal Investigator:||Petra Casey, MD||Mayo Clinic|