The Amenorrhea With Etonogestrel Implant

NCT ID: NCT05040282

Last Updated: 2023-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Implanon NXT

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Etonogestrel subdermal implant

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Khairy Ali

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Women Health Hospital - Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Implanon-nxt

Identifier Type: -

Identifier Source: org_study_id

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