Trial Condition(s):
Contraception
Return to fertility after discontinuation of contraception with Valette because of planned pregnancy
Bayer Identifier:
18863
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The main purpose of this observation was to acquire data on the return to fertility after discontinuation of Valette as an aspect of the tolerability and safety of this oral hormonal contraceptive (OC).
Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
Inclusion Criteria:
- Women with prescription of Valette (either as first OC or after switch from another OC) who discontinued the use of Valette because of wish to conceiveTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many locations, Germany | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Prospective, multicenter, non-interventional study on the return to fertility after discontinuation of oral contraception with Valette containing 0.03 mg ethinyl estradiol and 2.0 mg dienogest
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Kaplan-Meier estimates to measure the fraction of women becoming pregnant within a certain period of time after discontinuation of contraception with ValetteTimeframe: Up to one year
- Number of pregnancies within 1 year after end of Valette useTimeframe: Up to one year
- Time to conception after end of Valette useTimeframe: Up to one year
Secondary Outcome
- Pregnancy course and deliveryvaginal bleeding during pregnancy, gestational diabetes, drug abuse, nicotine and alcohol consumption, complications during pregnancy and deliveryTimeframe: Up to one year
- Pregnancy outcome and status of newborn(s)Basic data of newborn: sex, weight, body length, APGAR and Saling’s score, and commentsTimeframe: Up to one year
- Number of patients with adverse eventsTimeframe: Up to one year
Additional Information
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