Quickstarting oral contraceptive on Day 7-9 of menstruation, 4mg Drospirenone VS combined oral contraceptive pill, focusing on ovulation inhibition: A single-blind, randomized controlled, non-inferiority trial.
Phase 3
Completed
- Conditions
- Women with normal menstrual interval (24-38 days)4 mg drospirenone, progestin-only pill, quick start, ovulation
- Registration Number
- TCTR20220819001
- Lead Sponsor
- Thai red cross research committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 36
Inclusion Criteria
1. Women aged 18 to 45 years old
2. Body mass index 18 to 30 kg/m2
3. Agree to use a condom as contraception or be sterilized
4. Agree to participate in this study and complete an informed consent form
5. Menstruation interval within 24-38 days
Exclusion Criteria
1. History of estrogen, progestin or testosterone use within 3 months
2. Being pregnant or within 3 months of breastfeeding
3. Being a cervical cancer patient or having a precancerous cervical lesion
4. History of allergy to estrogen or progestin
5. Ovarian cyst or ovarian tumor
6. Any conditions in US Medical Eligibility Criteria 3 or 4 for progestin-only pills or combined oral contraceptive pills
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ovulation Every 2-3 days until ovulation or follicular structure-like less than 13 mm Modified Hoogland score
- Secondary Outcome Measures
Name Time Method Cervical mucus Every 2-3 days until ovulation or unfavorable cervical mucus archieved Modified WHO cervical mucus score with LH and progesterone level,Adverse effect Every follow-up day Patient reported outcome using patient's diary and assistant interview