Does Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?

Can a Three Months Treatment With Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?

Objective: The etonogestrel subdermal implant (ESI) is an effective and safe method of contraception. Although highly efficient, ESI produces often side effects that reduce its tolerance and acceptance. Daily oral desogestrel (DSG) prior to the insertion of ESI might help reduce its premature discontinuation. Our aim was to evaluate if this pre-treatment increases ESI's tolerance.

Methods: Between 15.08.2016 and 30.09.2019, the investigators conducted a randomized prospective study of women aged 18 to 42 years who were interested to use Implanon and were willing to have 90 days of pre-treatment with DSG, in the family planning clinic of the Geneva University Hospitals and the Hospital of Basel. Women were randomized into either the study ESI only group or to the DSG + ESI group. In the DSG + ESI group, patients were given a 3 months' supply of 75µg of DSG before the insertion of the ESI.

A 3 months visit was pre-programmed for all participants where the bleeding calendar and the questionnaires were collected. All patients were called over the phone after 12 months post ESI insertion in both groups.

Study Overview

• Status: Terminated
• Conditions: Contraception; Progestogen Adverse Reaction
• Intervention / Treatment: Drug: Implanon NXT® subdermal implant; Drug: Desogestrel 0.075 milligram

Detailed Description

Study and treatment periods

1 year of patient recruitment 15 months of follow up (90 days OD plus 1 year Implant or 1 year Implant)

Measurements and Procedures:

Assessment of premature ablation (PA) in months 3-12 (ESI only) or 3-15 (OD+ESI). This will require a contact with all patients at 12/15 months to verify if implant is still in place, and if it was removed, why (and possibly to also reassess symptoms).

Women with known PA can be exempted from this follow-up. In case of PA, reasons will be explored and questioned.

• Assessment of symptoms at 3 months only (bleeding calendar and satisfaction questionnaire, see below)
• Assessment of willingness to receive implant at 3 months in OD+ESI group data collection is limited to these items, in order to limit burden on participants, and to focus resources on high quality of data (as opposed to quantity).

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria:

• Women age of 18 - 42 years
• Interested in the use of ESI
• Accepting to have 90 days pre-treatment with OD
• Signed informed consent

Exclusion criteria:

• Pregnancy
• Lactation,
• vaginal bleeding of unknown origin,
• wish to become pregnant,
• weight over 80 kg,
• history of deep vein thrombosis/Pulmanory embolism,
• hypertension,
• Diabetes or other metabolic diseases,
• coagulation disorders,
• severe hepatic disorder,
• history of breast/endometrial cancer,
• known hypersensitivity to study drug,
• current treatment with enzyme inducing drugs (e.g.: phenytoin, carbamazepine, phenobarbital, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESI (Implanon NXT® subdermal implant); In this group, the implant was inserted immediately after thorough explanations of the potential side effects and possible adverse events	Drug: Implanon NXT® subdermal implant; Inserted immediately
Experimental: DSG + ESI(Desogestrel +Implanon NXT® subdermal implant); In this group, patients were given a 3 months' supply of 75µg of DSG to be started immediately after which insertion of an ESI was proposed. Similarly, explanations of the potential side effects and possible adverse events were presented to the patient before treatment initiation.	Drug: Implanon NXT® subdermal implant; Inserted immediately; Drug: Desogestrel 0.075 milligram; Inserted after 3 months use of DESOGESTREL; Other Names: Implanon NXT® subdermal implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance of Implanon	self-reported	at 1 year after implant insertion (or at ablation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discontinuation of implant,	frequency of ablation of any cause and due to intolerance; severity of specific symptoms at 1 year (or at ablation); severity of specific symptoms at 1 year (or at ablation)	at any time after insertion through study completion, an average of 1 year
specific symptoms	measured by questionnaires on bleeding patterns and satisfaction on a Likert scale	at 1 year after implant insertion

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Actual): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 29, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Progestins; Desogestrel; Etonogestrel
• Other Study ID Numbers: CCER 16-972

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No