NCT01658995

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

September 13, 2012

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 26, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

7.3 years

First QC Date

August 2, 2012

Results QC Date

December 7, 2020

Last Update Submit

January 6, 2021

Conditions

ESI-related Bleeding

Keywords

ImplanonEtonogestrel subdermal implantNexplanonContraceptionIrregular BleedingMenometrorrhagia

Outcome Measures

Primary Outcomes (1)

  • Secondary Treatment

    The proportion of subjects who requested additional secondary treatment of intervention after ESI

    After initial treatment up to 39 weeks

Secondary Outcomes (2)

  • Subject Satisfaction

    13 weeks post-treatment

  • Removal of ESI

    26 weeks post-randomization

Study Arms (2)

Post ESI implant - Doxycycline

ACTIVE COMPARATOR

Subjects will be randomized into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received Doxycycline 100 mg oral capsules, twice daily for 10 days. After 10 days, subsequent treatment can requested by the subjects

Drug: Doxycycline

Post ESI implant - Placebo

PLACEBO COMPARATOR

Subjects will be randomized into this arm after experiencing dissatisfaction with bleeding after 13 weeks post ESI insertion and received placebo 100 mg oral capsules, twice daily for 10 days. After 10 days, subsequent treatment can requested by the subjects

Drug: Placebo

Interventions

DoxycyclineDRUG

Doxycycline 100 mg oral capsules twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.

Also known as: Adoxa, Alodox, Avidoxy, Bio-Tab, Doryx, Doxy Lemmon, Doxy-Caps, Monodox, Morgidox, Ocudox, Oracea, Oraxyl, Periostat, Vibra-Tabs, Vibramycin
Post ESI implant - Doxycycline
PlaceboDRUG

Placebo, one capsule orally twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.

Also known as: Sugar pill
Post ESI implant - Placebo

Eligibility Criteria

Age18 Years - 51 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal women, aged 18-51 years
  • Expressed desire for compliance-independent contraception
  • No current pregnancy or anticipated desire for childbearing within 3 years of study enrollment and Implanon insertion
  • Agreement to participate in all study related procedures and evaluations as documented by a signed informed consent

You may not qualify if:

  • Current or prior use of Implanon
  • Current long-term use of Doxycycline for other indications
  • Known structural uterine abnormalities such as polyp, submucosal leiomyoma
  • Prior permanent sterilization or endometrial ablation
  • Pregnancy or desire for childbearing within 3 years
  • Contraindications to or intolerance of etonogestrel
  • Allergy to or intolerance of Doxycycline
  • Inability or unwillingness to complete study related procedures and evaluations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Interventions

DoxycyclineSugars

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsCarbohydrates

Results Point of Contact

Title
Petra M. Casey, M.D.
Organization
Mayo Clinic
Casey.Petra@mayo.edu
507-266-9873

Study Officials

  • Petra Casey, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Obstetrics - Gynecology

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 7, 2012

Study Start

September 13, 2012

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

January 26, 2021

Results First Posted

January 26, 2021

Record last verified: 2021-01

Locations

US(1)