The Amenorrhea With Etonogestrel Implant

Contraception Clinical Trial

Official title:

The Rate and Predictors of Amenorrhea at 1-year Follow-up in Women Using Etonogestrel Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05040282
• Other study ID #: Implanon-nxt
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Amenorrhea
• Contraception

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