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The Amenorrhea With Etonogestrel Implant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05040282
Recruitment Status : Recruiting
First Posted : September 10, 2021
Last Update Posted : February 14, 2022
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

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
Contraception Device: Implanon NXT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 1, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Etonogestrel subdermal implant




Primary Outcome Measures :
  1. Number of women with amenorrhea after using etonogestrel subdermal implant [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05040282


Locations
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Egypt
Women Health Hospital - Assiut university Recruiting
Assiut, Egypt, 71111
Contact: Mohammed K ALi, MD    +201005537951    m_khairy2001@yahoo.com   
Sponsors and Collaborators
Assiut University
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Responsible Party: Mohammed Khairy Ali, Assistant professor, Assiut University
ClinicalTrials.gov Identifier: NCT05040282    
Other Study ID Numbers: Implanon-nxt
First Posted: September 10, 2021    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amenorrhea
Menstruation Disturbances
Pathologic Processes
Etonogestrel
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female