The Amenorrhea With Etonogestrel Implant

NCT05040282 | Completed

• 1 other identifier: Implanon-nxt
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Number of women with amenorrhea after using etonogestrel subdermal implant

  1 year

Study Arms (1)

Etonogestrel 68 mg implant

OTHER

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

Interventions

Implanon NXT 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.

Also known as: Etonogestrel subdermal implant

Etonogestrel 68 mg implant

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Women with any contraindications for progesterone-only contraception in accordance with WHO eligibility criteria.
• Refuse participation in the study.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 21, 2021
• First Posted: September 10, 2021
• Study Start: October 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

EG (1)