Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorChulalongkorn University
About this trial
The goal of this clinical trial is to evaluate the effectiveness of transdermal contraceptive patches in treating irregular vaginal bleeding in women over 18 years old who are using contraceptive implants and experiencing abnormal vaginal bleeding. The main questions it aims to answer are:
* Does transdermal ethinyl estradiol and norelgestromin patch effectively treat irregular vaginal bleeding caused by contraceptive implants compared to placebo? * What proportion of participants will report cessation of vaginal bleeding during treatment and remain bleeding-free at day 14 of treatment? * What is the safety profile and adherence rate of the transdermal patch treatment?
Researchers will compare participants receiving active hormonal patches (ethinyl estradiol 600 mcg + norelgestromin 6 mg) to those receiving placebo patches to see if the hormonal treatment effectively stops irregular vaginal bleeding.
Participants will:
* Apply transdermal patches for 21 days (changing patch every 7 days - total of 3 patches) * Attend follow-up visits at days 7, 14, 21, and 3 months (day 14 in-person, others via telephone) * Complete bleeding diaries and report any side effects * Follow-up schedule:
Day 7: Telephone follow-up to assess bleeding pattern, side effects, and patch adherence Day 14: In-person visit at the clinic for comprehensive evaluation including bleeding assessment, side effects monitoring, and adherence check Day 21: Telephone follow-up to evaluate treatment completion, ongoing bleeding status, and need for additional treatment 3 months: Final telephone follow-up to assess long-term outcomes and recurrence of bleeding
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18 years and older
Regular menstrual cycles : at least 1 cycle prior to contraceptive implant insertion
Normal pelvic examination and transvaginal ultrasound results
Normal cervical cancer screening within the past 3 years
Disqualifiers
Previous treatment for irregular vaginal bleeding within the past 3 months
Pregnancy
Contraindications to estrogen or progestin use
Allergy to estrogen or progestin
Trial design
Design model
Parallel
Treatments tested in this trial
Transdermal Ethinyl Estradiol/Norelgestromin Patch
DrugTransdermal contraceptive patch containing ethinyl estradiol 600 micrograms and norelgestromin 6 milligrams per patch, manufactured by GEDEON RICHTER PLC and imported by Abbott.
Placebo Patch
DrugIdentical-appearing transdermal patches without active hormonal ingredients , manufactured and imported by Convatec.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 14
The proportion of study participants who report complete cessation of abnormal vaginal bleeding while receiving the transdermal contraceptive patch treatment and continue to report no vaginal bleeding on day 14 of the 21-day treatment period.
Time frame
day 14 of treatmentSecondary outcomes
1
Proportion of participants with at least 7 consecutive bleeding-free days during treatment month
Time frame
Throughout the treatment month (days 1-21 of treatment)2
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 7
Time frame
day 7 of treatment3
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 21
Time frame
day 21 of treatment4
Number of days of treatment required before cessation of vaginal bleeding
Time frame
From treatment initiation (day 1) until bleeding cessation, assessed throughout 21-day treatment periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov