Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-28 @ 5:24 AM
Study NCT ID:
NCT01963403
Status:
TERMINATED
Last Update Posted:
2017-05-12
First Post:
2013-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive
Sponsor:
University of California, Davis
Organization:
Study Overview
Official 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
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROBI
Brief Summary:
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
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
Detailed Description:
Women who are experiencing irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant will be recruited for this study. Women who have bothersome bleeding will be randomized to use either a combined oral contraceptive pill or a placebo pill.
Participants will take one pill every day and record their bleeding patterns on a daily diary.
Participants will have one screening/enrollment visit, two in-person follow up visits, and one telephone follow up contact. Subjects will be enrolled for a total of 84 days (three months).
Participants will be assigned to a treatment group at her screening/enrollment visit. Her first follow up visit will occur 22-28 days after her enrollment. Participants can choose to:
* Continue use of assigned treatment medication
* Discontinue use of assigned treatment medication, but use an open-label combined oral contraceptive pill
* Discontinue the use of assigned treatment medication, decline use of an open-label combined oral contraceptive pill
* Discontinue use of ETG implant.
Participants who choose to continue use of ETG implant will have a follow up telephone contact 50-56 days after her enrollment visit. A final in-person visit will occur 78-84 days after enrollment. Bleeding patterns will be assessed by daily bleeding diaries completed by the participant.
Participants will take one pill every day and record their bleeding patterns on a daily diary.
Participants will have one screening/enrollment visit, two in-person follow up visits, and one telephone follow up contact. Subjects will be enrolled for a total of 84 days (three months).
Participants will be assigned to a treatment group at her screening/enrollment visit. Her first follow up visit will occur 22-28 days after her enrollment. Participants can choose to:
* Continue use of assigned treatment medication
* Discontinue use of assigned treatment medication, but use an open-label combined oral contraceptive pill
* Discontinue the use of assigned treatment medication, decline use of an open-label combined oral contraceptive pill
* Discontinue use of ETG implant.
Participants who choose to continue use of ETG implant will have a follow up telephone contact 50-56 days after her enrollment visit. A final in-person visit will occur 78-84 days after enrollment. Bleeding patterns will be assessed by daily bleeding diaries completed by the participant.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MISP 50618 | OTHER_GRANT | Merck Sharp & Dohme Corp. | View |