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)

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) - HRA121022-001

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39702

Enrollment

Registered

2012-09-05

Start date

2013-02-19

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception contraception fertility control

Interventions

The study will start with a screening visit. During the inclusion visit standard medical assessments including safety laboratory tests (blood draw), a physical examination and a vital signs measurem

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Any contraindications to DSG or POP

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
- To test the interaction between UPA and DSG by comparing the effect of the 3 treatment regimens on time to ovulation and time to mucus blockage within the 21-day treatment period - To compare the effects of the three treatment regimens on the pharmacokinetics of UPA and DSG - To evaluate the safety and tolerability of the three treatment regimens	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)