Study on the Impact of LF111 and Drospirenone on Bone Health in Adolescent and Adult Women Using Oral Contraceptives

3 1 1 1

What is this study about?

This clinical trial is focused on studying the effects of hormonal contraceptives on bone health in women. The study involves the use of two types of chewable tablets: one containing the active ingredient drospirenone and another with a code name LF111. These medications are being compared to non-hormonal contraceptive methods to see how they affect bone mineral density, which is a measure of bone strength, in the lower back area over a period of 12 months.

The purpose of the study is to evaluate the impact of these hormonal contraceptives on bone health in adolescent and adult women. Participants will be divided into groups, with some taking the drospirenone or LF111 tablets, while others will use non-hormonal methods. The study will last for about a year, during which participants will undergo regular check-ups to monitor changes in their bone health and other health indicators like body weight and hormone levels.

Throughout the study, participants will be observed for any changes in their bone mineral density, as well as any side effects or changes in routine health measures. This research aims to provide valuable information on how hormonal contraceptives might affect bone health, helping to guide future healthcare decisions for women using these methods.

1 initial visit

Upon joining the study, an initial visit is conducted. During this visit, eligibility is confirmed based on criteria such as age, menstrual cycle regularity, and blood pressure.

Written informed consent is required before any trial-related procedures begin. For adolescents, assent is also necessary.

2 baseline assessment

A baseline assessment is performed to measure the bone mineral density (BMD) at the lumbar spine using a special scan called dual-energy X-ray absorptiometry (DXA).

Other baseline measurements include body weight, body mass index (BMI), and routine laboratory values.

3 medication administration

Participants are divided into two groups. One group receives drospirenone 3.5 mg chewable tablets, taken orally once daily for thirteen 28-day cycles.

The other group uses non-hormonal contraceptive methods for the duration of the trial.

4 follow-up visits

Regular follow-up visits are scheduled to monitor progress and collect data. These visits occur at intervals throughout the 12-month study period.

During these visits, changes in BMD, body weight, BMI, and laboratory values are assessed. Any adverse events are also recorded.

5 midpoint assessment

At the 6-month mark, a midpoint assessment is conducted. This includes a repeat of the DXA scan and evaluation of changes in laboratory values and serum estradiol levels for those in the hormonal treatment group.

6 final assessment

At the end of the 12-month period, a final assessment is conducted. This includes a final DXA scan to measure changes in BMD from the baseline.

Final evaluations of body weight, BMI, and laboratory values are also performed.

Who Can Join the Study?

Female participants with regular menstrual cycles, who have had their first period at least two years ago and have not yet gone through menopause, aged 14 to 45 years. For those aged 14 to 17, participation is allowed only if local laws permit them to consent to contraceptive services and participate in clinical trials.
Systolic blood pressure (the top number in a blood pressure reading) must be less than 140 mmHg, and diastolic blood pressure (the bottom number) must be less than 90 mmHg, measured while sitting after 5 minutes of rest.
For women who were previously pregnant, their menstruation must have restarted at least 6 months ago.
Must be able and willing to provide written consent to participate in the study. If the participant is an adolescent, they must provide assent, which is a form of agreement suitable for younger participants.
Must be willing to use the study’s contraceptive method for thirteen 28-day cycles or use non-hormonal contraceptive methods for the duration of the study.

Who Cannot Join the Study?

Participants cannot be male. Only female participants are allowed.
Participants must not be part of a vulnerable population. This means they should not be in a group that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Linden Sp. z o.o. sp.k.	Cracow	Poland
Stella-Gyn s.r.o.	Vodnany	Czechia
MUDr. Stepan s.r.o.	Hradec Kralove	Czechia
Gyncare MUDr. Michael Svec s.r.o.	Plzen 2-Slovany	Czechia
Gyncentrum Sp. z o.o.	Katowice	Poland

Other Sites

Site Name	City	Country
Vita Longa Sp. z o.o.	Katowice	Poland
Centra Medyczne Medyceusz Sp. z o.o.	Lodz	Poland
Creuyox Bemzhk Svc z odkn Sucr	Bialystok	Poland
Cpyfbaj acvvtgspzl gulnmmbczjm a psjljhoa pxxl sowkcr	Brno-Stred	Czechia
G Cekjipx Ojywziu stxttz	Olomouc	Czechia
Mgnff Ietbo Svqwqkflgd sdvleb	Vysoke Myto	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	30.08.2022
Poland	Not recruiting	30.08.2022

Trial locations

Investigated drugs:

DROSPIRENONE

LF111 is a medication being studied to see how it affects bone health in women. It is being compared to other methods that do not use hormones. The goal is to understand if using LF111 can change the strength and density of bones, particularly in the lower back, over a year of use.

Drospirenone is a type of hormonal medication that is being tested in the form of chewable tablets. This study is looking at how Drospirenone affects bone health in women, especially in the spine area, after a year of use. The researchers want to see if it has any impact on bone strength compared to women who do not use hormonal methods for contraception.

Oral contraception – Oral contraception refers to the use of hormone-based pills to prevent pregnancy. These pills typically contain synthetic forms of hormones such as estrogen and progestin. They work by inhibiting ovulation, altering the cervical mucus to prevent sperm penetration, and changing the uterine lining to prevent implantation. The effects on the body can include changes in menstrual cycle regularity and flow. Over time, users may experience variations in body weight and hormonal levels. The impact on bone mineral density, particularly in the lumbar spine, is also a subject of study.

Trial ID:

2024-512347-23-00

Protocol code:

LF111/401

NCT ID:

NCT05303636

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Impact of LF111 and Drospirenone on Bone Health in Adolescent and Adult Women Using Oral Contraceptives

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?