Trials Sponsors Conditions Drugs Pricing

Conditions

Prevention of pregnancy

Outcome Measures

Primary Outcomes (1)

Overall Pearl Index (PI) in non-breastfeeding women aged ≤ 35 years (at the time of trial enrolment).

Secondary Outcomes (22)

[Secondary efficacy:] Overall PI in women aged ≤ 35 years and in women > 35 years (at the time of trial enrolment).
[Secondary efficacy:] PI after correction for back-up contraception and sexual activity (evaluable cycles).
[Secondary efficacy:] PI after correction for back-up contraception and sexual activity (evaluable cycles) in women aged ≤ 35 years and in women > 35 years (at the time of trial enrolment).
[Secondary efficacy:] PI for method failure.
[Secondary efficacy:] PI for method failure in women aged ≤ 35 years and in women > 35 years (at the time of trial enrolment).
+17 more secondary outcomes

Interventions

Desirett 75 Mikrogramm FilmtablettenType not reported

Levonorgestrel Vaginal Delivery System 75Type not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Desirett 75 Mikrogramm Filmtabletten
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Desirett 75 Mikrogramm Filmtabletten
Named ingredient: Desogestrel
View registry record

Eligibility Criteria

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

[Visit 1a:] Sexually active, postmenarcheal and premenopausal female subjects ≥ 18 years at risk of pregnancy including breastfeeding women.
[Visit 1a:] Women who either a. have never used hormonal contraceptives before consent (naïve users), or b. have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent and a full menstrual cycle during the drug-free period (previous users) or c. directly switch from another hormonal contraceptive (switchers).

Sponsors & Collaborators

Chemo Research S.L.
Industrylead

Study Sites (72)

Medicinos Sprendimai UAB

Vilnius, 08108, Lithuania

Agnė Marcinkutė+37061690117 info@medklinika.lt

Inmedica UAB

Kaunas, 50177, Lithuania

Neringa Jakštienė+37061087881 njakstiene@yahoo.com

Hormodernus UAB

Kaunas, 48178, Lithuania

Kristina Jarienė+37069697979

Central Study Contacts

Chief Scientific Officer

+34917711500 Enrico.colli@exeltis.com

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

March 20, 2023

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2022-502024-51-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 03:16:38 UTC

Documents

K2_ Recruitment material - flyer

You may not qualify if:

[Visit 1a / Visit 1b:] Pregnancy or wish of pregnancy.
[Visit 1a:] Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary.
[Visit 1a:] History of infertility.
[Visit 1a:] Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a.
[Visit 1a:] Unexplained amenorrhea.
[Visit 1a:] Abnormal finding on pelvic, breast or ultrasound examination that in the investigator’s opinion contraindicates participation in the trial.
[Visit 1a:] Women - with a Papanicolaou (Pap) smear reading low-grade squamous intraepithelial lesion (LGSIL) or higher at screening. Subjects with atypical squamous cells of undetermined significance (ASC-US) can be included if they are negative for high-risk human papilloma virus (HPV) strains.
[Visit 1a:] Known contraindication including: a. Active venous thromboembolic disorder and/or a VTE history including a known positive family history in a sibling or parent. b. Arterial and cardiovascular disease, past or present (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease). c. Major surgery with prolonged immobilisation. d. Diabetes mellitus with vascular involvement. e. Presence or history of severe hepatic disease as long as liver function values have not returned to normal. f. Presence or history of liver tumours (benign or malignant). g. Known severe renal insufficiency or acute renal failure. h. Known adrenal insufficiency. i. Known or suspected sex steroid sensitive malignancies, including breast cancer. j. Hypersensitivity to the active substance, soya, peanut or to any of the excipients. k. Hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
[Visit 1a:] Uncontrolled concomitant chronic diseases (i.e., not on a stable treatment dose for at least 2 months at the time of consent).
[Visit 1a:] Severe COVID-19 disease or less than 3 months after hospitalization due to a COVID-19 disease.
[Visit 1a:] Known HIV infection.
[Visit 1a:] Known current or chronic hepatitis B or C.
[Visit 1a:] Gastrointestinal (malabsorptive) disease including inflammatory bowel disease (Crohn's disease or ulcerative colitis), gastric bypass surgery, current post gastrectomy syndrome and celiac disease.
[Visit 1a / Visit 1b:] Prohibited previous medication/therapy (as given in the protocol)
[Visit 1a / Visit 1b:] Dependence on prohibited co-medication/-therapy (as given in the protocol)
+5 more criteria

A pivotal, multicentre, randomised, open-label, parallel-group trial on contraceptive efficacy, safety and tolerability of LVDS (Levonorgestrel Vaginal Delivery System) during 9 cycles in comparison with Desogestrel tablets 0.075 mg.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (22)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (72)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (22)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (72)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations