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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:
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal Ethinyl Estradiol/Norelgestromin Patch | Drug | Transdermal contraceptive patch containing ethinyl estradiol 600 micrograms and norelgestromin 6 milligrams per patch, manufactured by GEDEON RICHTER PLC and imported by Abbott. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 14 of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with at least 7 consecutive bleeding-free days during treatment month | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tunchanok Juntamongkol, M.D. | Contact | +6626494000 | tunchanok.junt@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Planning Clinic, King Chulalongkorn Memorial Hospital | Recruiting | Pathum Wan | Bangkok | 10400 | Thailand |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2025 |
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|
| Placebo Patch | Drug | Identical-appearing transdermal patches without active hormonal ingredients , manufactured and imported by Convatec. |
|
| day 7 of treatment |
| Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 21 | day 21 of treatment |
| Number of days of treatment required before cessation of vaginal bleeding | From treatment initiation (day 1) until bleeding cessation, assessed throughout 21-day treatment period |
| Number of days of spotting/breakthrough bleeding during treatment | Throughout the 21-day treatment period |
| Number of days before recurrence of vaginal bleeding after treatment cessation | From end of treatment (day 21) until bleeding recurrence, assessed up to 3 months post-treatment |
| Treatment-related adverse events | Throughout treatment period (21 days) and follow-up period (3 months post-treatment) |
| Treatment adherence/compliance | Throughout the 21-day treatment period |
| Jul 21, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D008796 | Metrorrhagia |
| D014592 | Uterine Hemorrhage |
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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