A prospective, randomized, cross-over, single-blind, placebo-controlled study to assess the pharmacodynamic effects, pharmacokinetics and safety and tolerability of one dose of 30 mg ulipristal acetate (UPA) followed by the administration of 20 days of 75 µg desogestrel (DSG)

Completed

• Conditions: Contraception; fertility control; contraception

• Registration Number: NL-OMON39702
• Lead Sponsor: HRA Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

- Women between 18 and 35 years old
- No current use of hormonal contraception and having had at least one complete menstrual cycle since having stopped hormonal contraception

Exclusion Criteria

- Any contraindications to DSG or POP

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare the contraceptive effects (defined as a combination between<br /><br>occurrence of ovulation and cervical mucus) of the three following treatment<br /><br>regimens within the 21-day treatment period:<br /><br><br /><br>- 30 mg UPA single dose followed by 75 µg DSG per day for 20 days<br /><br>- 30 mg UPA single dose followed by one tablet of placebo per day for 20 days<br /><br>- One tablet of placebo followed by 75 µg DSG per day for 20 days </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To test the interaction between UPA and DSG by comparing the effect of the 3<br /><br>treatment regimens on time to ovulation and time to mucus blockage within the<br /><br>21-day treatment period<br /><br>- To compare the effects of the three treatment regimens on the<br /><br>pharmacokinetics of UPA and DSG<br /><br>- To evaluate the safety and tolerability of the three treatment regimens</p><br>