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Completed

NCT Number: NCT05040282

The Amenorrhea With 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.

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Key information

Conditions

Contraception

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implanon NXT

Device

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: Etonogestrel subdermal implant

Primary outcomes

  1. Number of women with amenorrhea after using etonogestrel subdermal implant

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 10, 2021
Registry last updated
Oct 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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