- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05040282
The Amenorrhea With Etonogestrel Implant
October 13, 2023 updated by: Mohammed Khairy Ali, Assiut University
The Rate and Predictors of Amenorrhea at 1-year Follow-up in Women Using Etonogestrel Implant
The etonogestrel subdermal implant has been available worldwide for more than 15 years.
The action of etonogestrel subdermal implant is principal via suppression of ovulation, but it also has effects on cervical mucus and in some women induces suppression of endometrial proliferation.
Several studies have confirmed its high efficacy and convenience.
The uterine bleeding problems and in particular irregular bleeding and amenorrhea are major side effects of etonogestrel subdermal implant.
A considerable number of patients request early removal due to bleeding changes.
Amenorrhea occurs in about 22% in etonogestrel subdermal implant users.
Despite the presence of many studies that reported the prevalence of etonogestrel subdermal implant-associated bleeding, little is known about the predictive factors affecting menstrual bleeding patterns especially amenorrhea after etonogestrel subdermal implant insertion.
These predictive factors should be provided prior to the etonogestrel subdermal implant insertion which may improve acceptance and continuation of etonogestrel subdermal implant.
Study Overview
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Assiut, Egypt, 71111
- Women Health Hospital - Assiut university
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Women aged between 18 and 40 years.
- Women who are not lactating.
- Non-pregnant women
- Women have regular menstrual cycles every 21-35 days with a typical cycle length variation of no more than 5 days.
- Women who will ESI only for pregnancy prevention for at least 12 months.
- Have not any medical or gynecologic problems.
Exclusion Criteria:
- Women with any contraindications for progesterone-only contraception in accordance with WHO eligibility criteria.
- Refuse participation in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Etonogestrel 68 mg implant
Women will be subjected to etonogestrel 68 mg implant insertion (Implanon NXT; Organon, USA Inc) according to manufacture instructions.
The insertion will be within the first 5 days of the menstrual cycle
|
women will be subjected to etonogestrel 68 mg implant insertion.
Participants will be trained on how to fill the menstrual diary.
The menstrual diary includes information about days of bleeding and spotting days.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of women with amenorrhea after using etonogestrel subdermal implant
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Actual)
August 1, 2023
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
August 21, 2021
First Submitted That Met QC Criteria
September 3, 2021
First Posted (Actual)
September 10, 2021
Study Record Updates
Last Update Posted (Actual)
October 16, 2023
Last Update Submitted That Met QC Criteria
October 13, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Implanon-nxt
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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