Oral Contraceptive for Birth Control

No longer recruiting at 48 trial locations

Overseen By Vanna S Gold

Age: < 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Insud Pharma

Must not be taking: Barbiturates, Anticonvulsants, Rifampin, others

Disqualifiers: Pregnancy, Amenorrhea, Thromboembolism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral contraceptive, LPRI-CF113 (containing Drospirenone), to evaluate its effectiveness in preventing pregnancy and its safety. Beyond its role as birth control, the trial examines its impact on bone health, focusing on bone density in areas like the spine and hips after one year of use. Healthy, sexually active women at risk for pregnancy may be suitable candidates, particularly those aged 18 to 45 with regular menstrual cycles. Participants will use this contraceptive for 13 cycles and report their experiences. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to a potentially groundbreaking contraceptive option.

Do I need to stop my current medications to join the trial?

The trial requires you to stop taking certain medications that can interfere with hormonal contraceptives, such as some anticonvulsants, antibiotics, and herbal products like St. John's Wort. If you are on any of these, you may need to stop them before joining the trial. There is also a 12-month washout period for those taking oral or intravenous glucocorticoids.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that drospirenone, the main ingredient in LPRI-CF113, is generally safe for most people. Studies indicate it does not increase the risk of serious issues like high potassium levels, heart rhythm problems, or birth defects. However, the chance of developing blood clots is slightly higher, particularly for smokers. This risk is about 1.5 times higher compared to some other birth control pills. Overall, drospirenone is well-tolerated, but considering these risks and discussing them with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LPRI-CF113 for birth control because it not only aims to prevent pregnancy effectively, but it also investigates its impact on bone mineral density, which is an area not typically addressed by standard contraceptives like combined estrogen-progestin pills or progestin-only options. Unlike most oral contraceptives that primarily focus on efficacy and safety, this treatment explores additional health benefits, potentially offering a dual advantage for users concerned about bone health. This unique focus on bone mineral density could make it particularly appealing to individuals in the 18-45 age group who are mindful of long-term health impacts.

What evidence suggests that this treatment might be an effective contraceptive?

Research has shown that drospirenone, the main ingredient in LPRI-CF113, is highly effective for birth control. Even if a pill is missed for up to 24 hours, it maintains its effectiveness. For women aged 35 or younger, its effectiveness is indicated by a low Pearl Index, a standard measure of birth control efficacy. Results from several studies confirm drospirenone as a reliable option. It is effective for both non-obese and obese women, demonstrating consistent performance regardless of body weight. This evidence supports LPRI-CF113 as a trustworthy birth control choice. ^{1 6 7 8 9}

Who Is on the Research Team?

Enrico Colli, MD

Principal Investigator

Chemo Research SL

Are You a Good Fit for This Trial?

This trial is for healthy, sexually active females aged 13-45 who are not pregnant or trying to become pregnant and do not plan to use other contraceptives. They must have regular menstrual cycles and a BMI of at least 18 kg/m2. Participants should be willing to engage in intercourse without additional contraception methods and agree to take the study drug for over a year. Those with certain health conditions or taking medications that affect bone density are excluded.

Inclusion Criteria

Subjects must have a BMI of 18 kg/m2 or higher

Subjects must not be enrolled or plan to enroll in any other clinical study during the study period

Subjects must be regularly menstruating (with cycle length between 21 and 35 days) for at least 3 months prior to the signing of the Informed Consent Form

Exclusion Criteria

My recent ultrasound showed unusual results.

The subject has any ongoing condition or history of medical illness that in the opinion of the Investigator may jeopardize the conduct of the study or impact screening

My recent Pap smear showed abnormal cells.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive LPRI-CF113 orally for 13 medication cycles to evaluate contraceptive efficacy, safety, and tolerability

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extended Follow-up (Part B)

Subgroup of participants are monitored for changes in bone mineral density using DXA scans

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Drospirenone

Trial Overview

The trial tests LPRI-CF113's effectiveness as an oral contraceptive (Part A) and its impact on bone mineral density, particularly in the lumbar spine after one year (Part B). It also examines safety and tolerability, along with effects on bone turnover at various body sites.

How Is the Trial Designed?

Group I: Part B - The effect of LPRI-CF113 on bone mineral density in a subgroup age 18-45 Experimental Treatment 1 Intervention

A subgroup of subjects from Part A that are age 18-45 and without further exclusion criteria to Part B will be enrolled in Part B of the study. Part B of the study will investigate the effects of LPRI-CF113 on bone mineral density.

Group II: Part A - An investigation of the efficacy, safety, and tolerability of LPRI-CF113 Experimental Treatment 1 Intervention

All subjects enrolled in the study will participate in Part A of the study. Part A of the study will investigate the efficacy, safety, and tolerability of LPRI-CF113.

Who Is Running the Clinical Trial?

Insud Pharma

Lead Sponsor

Trials

9

Recruited

24,300+

Chemo Research

Industry Sponsor

Trials

6

Recruited

4,900+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05461573

Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral ...

This study will be in two parts, Part A and Part B. The primary objective of Part A is to evaluate the contraceptive efficacy of LPRI-CF113.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7286157/

A 1-year prospective, open-label, single-arm, multicenter ...

Drospirenone maintains contraceptive effectiveness even with 24-h delayed or missed-pill errors [16]. Among nonbreastfeeding women aged ≤ 35 years, the Pearl ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26232513/

Drospirenone-only Oral Contraceptive: Results From a ...

The primary efficacy endpoint was the overall Pearl Index (PI). Bleeding patterns, changes in vital signs and changes in laboratory values were also analyzed.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0010782422002153

Pooled efficacy results of estetrol/drospirenone combined ...

Pooled results from two phase 3 trials demonstrate high contraceptive efficacy of the novel estetrol-drospirenone oral contraceptive.

5.

contraceptionjournal.org

contraceptionjournal.org/article/S0010-7824(23)00230-5/fulltext

The efficacy, safety, and tolerability of an estrogen-free oral ...

Drospirenone 4 mg demonstrated similar contraceptive efficacy for both nonobese and obese users despite a difference in exposure based on bodyweight.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/15471507/

Safety of a new oral contraceptive containing drospirenone

EE/DRSP is not associated with any increased risk of other serious adverse events such as hyperkalaemia, cardiac arrhythmia or birth defects.

7.

fda.gov

fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-safety-review-update-possible-increased-risk-blood-clots-birth-control

risk of blood clots with birth control pills containing ...

Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing ...

8.

mayoclinic.org

mayoclinic.org/drugs-supplements/drospirenone-and-ethinyl-estradiol-oral-route/description/drg-20061917

Drospirenone and ethinyl estradiol (oral route)

If you smoke while using birth control pills containing drospirenone, you increase your risk of having a blood clot, heart attack, or stroke.

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S001078242200395X

Tolerability and safety of the estetrol/drospirenone ...

To evaluate tolerability and safety of estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg oral contraceptive using pooled data from two, multicenter, phase 3 trials.