The Amenorrhea With Etonogestrel Implant

Study Overview
=================
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.

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

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Device: Implanon NXT


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Etonogestrel 68 mg implant<br>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 | Device: Implanon NXT<br>* 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.<br>* Other names: Etonogestrel subdermal implant;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of women with amenorrhea after using etonogestrel subdermal implant |  | 1 year |