Clincosm LogoSign in Get a demo

The Amenorrhea With Etonogestrel Implant

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05040282
Collaborator
(none)
300
Enrollment
1
Location
1
Arm
26
Anticipated Duration (Months)
11.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Implanon NXT
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Rate and Predictors of Amenorrhea at 1-year Follow-up in Women Using Etonogestrel Implant
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Etonogestrel 68 mg implant

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
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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Women Health Hospital - Assiut university Assiut Egypt 71111

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohammed Khairy Ali, Assistant professor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05040282
    Other Study ID Numbers:
    • Implanon-nxt
    First Posted:
    Sep 10, 2021
    Last Update Posted:
    Feb 14, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Amenorrhea
    Etonogestrel

    Study Results

    No Results Posted as of Feb 14, 2022