Cervical Mucus, Serum Hormonal Profile, Ultrasound Finding: Ovulation Inhibition, Ovarian Activities
Conditions
Keywords
Quick starting contraception, Quadriphasic combined hormonal contraceptive pill(s), Estradiol valerate/Dienogest, Ovulation inhibition
Brief summary
The goal of this clinical trial is to learn if Estetrol/Drospirenone inhibit ovulation in quick-starting method. It will also learn about the safety of Estetrol/Drospirenone. The main questions it aims to answer are: Does Estradiol valerate/Dienogest inhibit ovulation inferior to Ethinyl estradiol/Gestodene when starting on Day 7-9 of menstrual cycle? What are the impacts of Estradiol valerate/Dienogest on ovarian activities when starting on Day 7-9 of menstrual cycle? How does the cervical mucus change when starting Estradiol valerate/Dienogest on Day 7-9 of menstrual cycle? What are the adverse effects when starting Estradiol valerate/Dienogest on Day 7-9 of menstrual cycle? Researchers will compare Estradiol valerate/Dienogest to Ethinyl estradiol/Gestodene to see if Estradiol valerate/Dienogest inhibit ovulation in quick-starting method.
Detailed description
Take Estradiol valerate/Dienogest or Ethinyl estradiol/Gestodene starting on day 7-9 of menstrual cycle then every day for 1 pack of the pills. Visit the clinic on day 1-2, day 7-9, and then every 2-7 days according to ultrasound finding (ovarian activities) until completing of pills to investigate * Transvaginal ultrasound * Cervical mucus * Serum hormonal profiles.
Interventions
DRUGQuadriphasic Estradiol valerate 1 - 3 mg/ Dienogest 2 - 3 mg (26/2)
Completing a pack (28 pills) of Quadriphasic Estradiol valerate 1 - 3 mg/ Dienogest 2 - 3 mg (26/2), starting on day 7-9 of menstrual cycle
Completing a pack (28 pills) of Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7), starting on day 7-9 of menstrual cycle
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) as control group Quadriphasic Estradiol valerate 1 - 3 mg/ Dienogest 2 - 3 mg (26/2) as intervention group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 18 - 45 years old * Body mass index 18-30 kg/m² * Menstrual interval within 24 - 38 days * Absence of history of estrogen or progestin allergy and Absence of these compatibles with U.S. medical eligibility criteria category 3 - 4 * Consent to use condom as contraception or have been sterilized
Exclusion criteria
* History of estrogen, progestin or testosterone use within 3 months * Current pregnant or within 3 months of breastfeeding * Having ovarian cyst(s) or tumor(s) * Being a cervical cancer patient or having precancerous cervical lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of ovulation inhibition and classify ovarian activities using transvaginal ultrasound | 34-36 days | Visit the clinic on day 1-2, day 7-9, and then every 2-7 days according to ultrasound finding until completing a package of pills * Ultrasound will be perform by the researcher (Dr. Sirarat Itthipuripat) using transvaginal probe to all volunteers. * To monitor a leading ovarian follicle or follicle-like structures (FLS), that the ultrasound characteristic is the largest hypoechoic part (follicle) among both ovaries, to classify the ovarian activity by modified Hoogland's score (combined the result with hormonal profile: Estradiol, Progesterone) and assess rate of ovulation, that identify from postovulatory image defined as follows: * Image observed after abrupt disappearance of FLS or * Image observed after reduction in size of the leading follicle \> 4 mm at 2 consecutive visits or * Hemorrhagic or cystic corpus luteum * The detail in measuring the size of an FLS is the average of 3 longest sides perpendicular to each other in millimeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of serum hormonal profiles: Estradiol, Progesterone, LH | 34-36 days | Visit the clinic on day 1-2, day 7-9, and then every 2-7 days according to ultrasound finding * Blood test to measure estrogen level in picogram/milliliter, progesterone level in nanogram/milliliter and LH level in International unit per liter * Volunteers will be placed in a 5 ml clot activator tube and sent to the endocrinology laboratory medical operation center within 30 minutes after blood draw. |
| Cervical mucus classification | 34-36 days | Visit the clinic on day 1-2, day 7-9, and then every 2-7 days according to ultrasound finding * Using Tuberculin syringe 1 mL to suck cervical mucus from the endocervical canal (1 cm deep from external cervical os) * Assess the results of cervical mucus collected immediately according to WHO 2010, consisting of volume (milliliter), viscosity, ferning appearance, Spinnbarkeit (centimeter), and cellularity (cell/high power field), under microscopy |
Countries
Thailand
Contacts
STUDY_DIRECTORSomsook Santibenchakul, Master
Obstetric and gynecology department, Faculty of medicine, Chulalongkorn University
Outcome results
None listed