Vaginal bleeding irregularities Contraceptive implant Transdermal contraceptive patch Contraceptive Devices, Female / adverse effects Estrogens Uterine Hemorrhage* / drug therapy Uterine Hemorrhage* / etiology
Conditions
Interventions
Transdermal Ethinyl estradiol and Norelgestromin consists of 600 microgram of ethinylestradiol and 6milligram of norelgestromin.
The participant applies the first patch for 7 days at the first day o
Experimental Drug,Placebo Comparator Drug
Transdermal Ethinyl estradiol and Norelgestromin ,Placebo
Sponsors
Faculty of Medicine Chulalongkorn University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 14 Day14 Apparent data | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with at least 7 consecutive bleeding-free days during treatment month Day1-21 Apparent data,Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 7 Day7 Apparent data,Proportion of participants reporting cessation of vaginal bleeding during treatment and remaining bleeding-free at day 21 Day21 Apparent data,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 Apparent data,Number of days of spotting/breakthrough bleeding during treatment Throughout the 21-day treatment period Apparent data,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 Apparent data,Treatment-related adverse events Throughout treatment period (21 days) and follow-up period (3 months) Apparent data,Treatment adherence/compliance Day 21 Apparent data | — |
Countries
Thailand
Contacts
Public ContactTunchanok Juntamongkol
Faculty of Medicine Chulalongkorn university
Outcome results
None listed