Menstruation DisturbancesPhase 2NCT07083635
Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users
A Phase 2 study testing Transdermal Ethinyl Estradiol/Norelgestromin Patch in people with Menstruation Disturbances and Metrorrhagia, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menstruation Disturbances, Metrorrhagia, Uterine Hemorrhage
- What is being tested?
- Transdermal Ethinyl Estradiol/Norelgestromin Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 29 Jul 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Irregular vaginal bleeding defined as: Bleeding for more than 8 consecutive days, or Bleeding-free intervals of 15 days or less
Who cannot join
- Previous treatment for irregular vaginal bleeding within the past 3 months
- Pregnancy
- Contraindications to estrogen or progestin use
- Allergy to estrogen or progestin
- Allergy to hormonal patches
- Heavy vaginal bleeding causing anemia symptoms such as: Fatigue/Fainting/Dizziness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Family Planning Clinic, King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10400
Tunchanok Juntamongkol, Doctor of Medicine, +66818084336, tunchanok.junt@gmail.com
About this study
Official title: Transdermal Ethinyl Estradiol and Norelgestromin for Treating Irregular Vaginal Bleeding in Contraceptive Implant Users: A Randomized, Double-Blind, Controlled 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?
Read more
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
- Being tested
- Transdermal Ethinyl Estradiol/Norelgestromin Patch, Placebo Patch
- Keywords
- Contraceptive implant, Abnormal vaginal bleeding, Bothersome vaginal bleeding, Irregular vaginal bleeding, Transdermal hormonal contraception, Ethinyl estradiol, Norelgestromin, Abnormal uterine bleeding, Contraceptive-induced bleeding, Combined hormonal contraception, Hormonal contraceptive patch
- Medical subject headings
- Menstruation Disturbances, Metrorrhagia, Uterine Hemorrhage, Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal Ethinyl Estradiol/Norelgestromin PatchDrug
Also called Ethinyl Estradiol and Norelgestromin Transdermal Patch, Transdermal Contraceptive Patch, Combined Hormonal Contraceptive Patch, Hormonal Patch
Transdermal contraceptive patch containing ethinyl estradiol 600 micrograms and norelgestromin 6 milligrams per patch, manufactured by GEDEON RICHTER PLC and imported by Abbott.
Placebo PatchDrug
Identical-appearing transdermal patches without active hormonal ingredients , manufactured and imported by Convatec.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Transdermal Hormonal Contraceptive Patch (Ethinyl Estradiol and Norelgestromin)
Active Ingredients:
Ethinyl Estradiol: 600 micrograms per patch Norelgestromin: 6 milligrams per patch
Administration Schedule:
1 patch applied every 7 days Total treatment duration: 21 days (3 patches total) Application Site: Upper torso (same as active treatment) Receives: Drug: Transdermal Ethinyl Estradiol/Norelgestromin Patch |
| Placebo | Placebo comparator | Placebo Transdermal Patch
Detailed Description:
Active Ingredients: None (placebo patch with identical appearance)
Administration Schedule:
1 patch applied every 7 days Total treatment duration: 21 days (3 patches total) Application Site: Upper torso (same as active treatment) Receives: Drug: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 14 of treatment
Secondary outcomes (8)
Proportion of participants with at least 7 consecutive bleeding-free days during treatment month
Measured: Throughout the treatment month (days 1-21 of treatment)
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 7
Measured: day 7 of treatment
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 21
Measured: day 21 of treatment
Number of days of treatment required before cessation of vaginal bleeding
Measured: From treatment initiation (day 1) until bleeding cessation, assessed throughout 21-day treatment period
Number of days of spotting/breakthrough bleeding during treatment
Measured: Throughout the 21-day treatment period
Number of days before recurrence of vaginal bleeding after treatment cessation
Measured: From end of treatment (day 21) until bleeding recurrence, assessed up to 3 months post-treatment
Treatment-related adverse events
Measured: Throughout treatment period (21 days) and follow-up period (3 months post-treatment)
Treatment adherence/compliance
Measured: Throughout the 21-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start29 Jul 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstruation DisturbancesStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tunchanok Juntamongkol, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083635
- Sponsor's protocol ID
- 107/68
- Status last verified
- Dec 2025
- First submitted
- 13 Jul 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Ethinyl Estradiol and Norelgestromin for Treating Irregular Vaginal Bleeding in Contraceptive Implant Users: A Randomized, Double-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT07083635
- Acronym / sponsor ID
- 107/68
- Keywords
- Contraceptive implant, Abnormal vaginal bleeding, Bothersome vaginal bleeding, Irregular vaginal bleeding, Transdermal hormonal contraception, Ethinyl estradiol, Norelgestromin, Abnormal uterine bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Transdermal Ethinyl Estradiol/Norelgestromin PatchTransdermal Hormonal Contraceptive Patch (Ethinyl Estradiol and Norelgestromin) Active Ingredients: Ethinyl Estradiol: 600 micrograms per patch Norelgestromin: 6 milligrams per patch Administration Schedule: 1 patch applied every 7 days Total treatment duration: 21 days (3 patches total) Application Site: Upper torso (same as active treatment) |
| Placebo | Placebo comparator | Drug: Placebo PatchPlacebo Transdermal Patch Detailed Description: Active Ingredients: None (placebo patch with identical appearance) Administration Schedule: 1 patch applied every 7 days Total treatment duration: 21 days (3 patches total) Application Site: Upper torso (same as active treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Irregular vaginal bleeding defined as: Bleeding for more than 8 consecutive days, or Bleeding-free intervals of 15 days or less
Key exclusion criteria (6 listed)
- Previous treatment for irregular vaginal bleeding within the past 3 months
- Pregnancy
- Contraindications to estrogen or progestin use
- Allergy to estrogen or progestin
- Allergy to hormonal patches
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal Ethinyl Estradiol/Norelgestromin PatchAlso: Ethinyl Estradiol and Norelgestromin Transdermal Patch, Transdermal Contraceptive Patch, Combined Hormonal Contraceptive Patch, Hormonal PatchTransdermal contraceptive patch containing ethinyl estradiol 600 micrograms and norelgestromin 6 milligrams per patch, manufactured by GEDEON RICHTER PLC and imported by Abbott. | Drug | Treatment |
| Placebo PatchIdentical-appearing transdermal patches without active hormonal ingredients , manufactured and imported by Convatec. | Drug | Placebo |
Primary outcome
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 14
Time frame: day 14 of treatment
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.
8 secondary outcomes
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)
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 7
Time frame: day 7 of treatment
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 21
Time frame: day 21 of treatment
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 period
Number of days of spotting/breakthrough bleeding during treatment
Time frame: Throughout the 21-day treatment period
Number of days before recurrence of vaginal bleeding after treatment cessation
Time frame: From end of treatment (day 21) until bleeding recurrence, assessed up to 3 months post-treatment
Treatment-related adverse events
Time frame: Throughout treatment period (21 days) and follow-up period (3 months post-treatment)
Treatment adherence/compliance
Time frame: Throughout the 21-day treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transdermal Ethinyl Estradiol/Norelgestromin Patch in people with Menstruation Disturbances and Metrorrhagia, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tunchanok Juntamongkol, M.D. (+6626494000, tunchanok.junt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 14 (time frame: day 14 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.