Table of Contents
- Clinical trials overview
- Contraception and pregnancy prevention studies
- Migraine studies
- Brain, mood, and behavior study
- Drug level study in healthy women
- Post-abortion contraception study
- Endometrial cancer study
Clinical trials overview
The trials in this article study Levonorgestrel in different forms, including oral tablets, a vaginal delivery system, and an intrauterine system.[1][2][3][4][5][6][7][8]
Most studies focus on contraception, which means preventing pregnancy, but other trials look at migraine, mood, thinking skills, brain measures, and treatment-related outcomes in endometrial cancer.[1][2][3][4][5][6][7][8]
The studies include Phase 1, Phase 2, and Phase 3 trials, plus one low-intervention randomized controlled trial.[1][2][3][4][5][6][7][8]
Contraception and pregnancy prevention studies
Several trials study Levonorgestrel for pregnancy prevention and contraceptive effectiveness.[3][4][5]
One completed Phase 3 trial tested a Levonorgestrel Vaginal Delivery System for 13 cycles in non-breastfeeding women aged 18 to 35 years, and its main outcome was the Pearl Index, a standard measure of pregnancy prevention success.[3]
Another completed Phase 3 study compared the same vaginal delivery system with desogestrel tablets over 9 cycles in non-breastfeeding women aged 35 years or younger, and it also used the Pearl Index as the main outcome.[4]
A Phase 2 study looked at whether ovulation stayed blocked even when tablet intake was delayed on purpose, using an oral Levonorgestrel tablet for three 28-day cycles.[5]
These studies show that researchers are not only checking whether Levonorgestrel works for contraception, but also whether it keeps working under real-life use problems such as missed or late tablets.[5]
Migraine studies
One authorised trial studies continuous daily use of ethinylestradiol/Levonorgestrel compared with vitamin E in women with menstrually-related migraine, pure menstrual migraine, or perimenopausal migraine.[2]
This is a randomized controlled trial with 360 participants, and the main outcome is the change in monthly migraine days over a 28-day period at the 12-week time point.[2]
The study is split into two groups of women: one group with migraine linked to menstruation and one group with migraine around menopause.[2]
This trial is important because it measures a clear symptom outcome that patients can understand: how often migraine happens each month.[2]
Brain, mood, and behavior study
The BECONTRA study is a Phase 3 trial looking at the effects of common oral contraceptives that include EE/LNG, meaning ethinylestradiol/Levonorgestrel, and another oral contraceptive option, on the brain and behavior.[1]
The study plans to enroll 600 participants and will assess mood, self-perception, cognition, brain structure, and brain function after up to 6 months of treatment.[1]
It also studies whether these effects change back after stopping treatment, which is called reversibility upon withdrawal.[1]
Outcomes include premenstrual symptoms, positive and negative affect, depression, anxiety, gender role, face recognition, verbal fluency, navigation, and working memory.[1]
Drug level study in healthy women
One Phase 1 trial in healthy women studied whether BI 425809 changes the blood levels of ethinylestradiol and Levonorgestrel when taken together as the combined oral contraceptive Microgynon.[7]
This trial had only 16 participants and measured pharmacokinetics, which means how much of the medicine is in the blood over time.[7]
The main outcomes were area under the curve, maximum concentration, and minimum concentration at steady state, which are ways to describe blood exposure to a medicine after repeated doses.[7]
Post-abortion contraception study
One Phase 3 trial studied immediate insertion of intrauterine contraception after medical abortion, compared with insertion 2 to 4 weeks later.[6]
The study includes intrauterine systems such as Mirena, Kyleena, and Jaydess, and it plans to enroll 720 women.[6]
The main outcome is the proportion of women using intrauterine contraception at 6 months after abortion, which helps show whether immediate placement improves continued contraceptive use.[6]
Endometrial cancer study
One Phase 2 trial studies women living with endometrial adenocarcinoma, which is a cancer of the lining of the uterus, and includes Mirena as part of the treatment groups.[8]
The trial plans to enroll 78 participants and measures pathological complete response, or pCR, at 12 months.[8]
In this study, pCR means there is no endometrial adenocarcinoma or endometrial hyperplasia found on biopsy after treatment.[8]
This trial shows that Levonorgestrel-related treatment is being studied not only for contraception, but also in a cancer setting where tissue changes are measured carefully.[8]
