The Amenorrhea With Etonogestrel Implant

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05040282

Enrollment

300

Registered

2021-09-10

Start date

2021-10-01

Completion date

2023-09-01

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

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.

Interventions

DEVICEImplanon 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Number of women with amenorrhea after using etonogestrel subdermal implant	1 year

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026