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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05040282
Other study ID # Implanon-nxt
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date September 1, 2023

Study information

Verified date October 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date September 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: 1. Women aged between 18 and 40 years. 2. Women who are not lactating. 3. Non-pregnant women 4. Women have regular menstrual cycles every 21-35 days with a typical cycle length variation of no more than 5 days. 5. Women who will ESI only for pregnancy prevention for at least 12 months. 6. Have not any medical or gynecologic problems. Exclusion Criteria: 1. Women with any contraindications for progesterone-only contraception in accordance with WHO eligibility criteria. 2. Refuse participation in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Implanon NXT
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.

Locations

Country Name City State
Egypt Women Health Hospital - Assiut university Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of women with amenorrhea after using etonogestrel subdermal implant 1 year
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