Management of Etonogestrel Subdermal Implant-related Bleeding

ESI-related Bleeding Clinical Trial

Official title:

Management of Etonogestrel Subdermal Implant-related Bleeding in US Women: a Prospective, Randomized, Placebo-controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658995
• Other study ID #: 11-008933
• Status: Completed
• Phase: Phase 3
• Start date: September 13, 2012
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 51 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• ESI-related Bleeding
• Hemorrhage

Intervention

Drug:
• Doxycycline
Doxycycline 100 mg oral capsules twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.
• Placebo
Placebo, one capsule orally twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Petra M. Casey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Secondary Treatment	The proportion of subjects who requested additional secondary treatment of intervention after ESI	After initial treatment up to 39 weeks
Secondary	Subject Satisfaction	Number of subjects who reported satisfaction with bleeding after 13 weeks post ESI insertion. As measured by the number of subjects answering very satisfied or satisfied on the Patient Satisfaction Survey question "To what extent have you been satisfied overall while using the contraceptive implant? Very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied or very dissatisfied."	13 weeks post-treatment
Secondary	Removal of ESI	Number of subjects who requested ESI removal	26 weeks post-randomization

External Links

•   Mayo Clinic Clinical Trials