Back to resultsThe Amenorrhea With Etonogestrel Implant
Primary Purpose
Contraception
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Implanon NXT
Sponsored by
About this trial
This is an interventional other trial for Contraception
Eligibility Criteria
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.
Sites / Locations
- Women Health Hospital - Assiut university
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Etonogestrel 68 mg implant
Arm Description
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
Outcomes
Primary Outcome Measures
Number of women with amenorrhea after using etonogestrel subdermal implant
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05040282
Brief Title
The Amenorrhea With Etonogestrel Implant
Official Title
The Rate and Predictors of Amenorrhea at 1-year Follow-up in Women Using Etonogestrel Implant
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etonogestrel 68 mg implant
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Implanon NXT
Other Intervention Name(s)
Etonogestrel subdermal implant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of women with amenorrhea after using etonogestrel subdermal implant
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Amenorrhea With Etonogestrel Implant
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