Oral Contraceptive for Birth Control

Recruiting at 24 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

1009 Participants Needed

Trial Summary

What is the purpose of this trial?

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. The secondary objective of Part A is to evaluate the safety and tolerability of LPRI-CF113. The primary objective of Part B is to evaluate the impact of LPRI-CF113 on bone mineral density (BMD) at the lumbar spine (L1-L4) after 12 months (13 medication cycles). The secondary objective of Part B is to evaluate the impact of LPRI-CF113 on BMD and bone turnover after 12 months (13 medication cycles) at the femoral neck, total hip, and total body.

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.

What data supports the effectiveness of the drug Drospirenone for birth control?

Research shows that drospirenone, when combined with other hormones like estetrol or ethinyl estradiol, is effective as a birth control pill. It has similar effectiveness to other low-dose oral contraceptives and may offer additional benefits like improved mood and reduced acne. ^{1 2 3 4 5}

Is drospirenone safe for use in oral contraceptives?

Drospirenone-containing oral contraceptives have been shown to have a good safety profile, similar to other low-dose oral contraceptives. Studies have not found an increased risk of serious conditions like hyperkalemia (high potassium levels) or thromboembolic events (blood clots) compared to other contraceptives. ^{1 6 7 8 9}

How does the drug drospirenone differ from other birth control options?

Drospirenone is unique because it mimics natural progesterone and has additional properties that help reduce water retention and acne, and it can also improve mood-related symptoms like those in premenstrual dysphoric disorder (PMDD). Unlike traditional oral contraceptives, it can be used in a 24/4 regimen, which may improve bleeding patterns and maintain hormone levels more consistently. ^{1 10 11 12 13}

Research Team

Enrico Colli, MD

Principal Investigator

Chemo Research SL

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Drospirenone: a novel progestin. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A 1-year prospective, open-label, single-arm, multicenter, phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only pill drospirenone 4 mg using a 24/4-day regimen. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Estetrol-drospirenone combination oral contraceptive: North American phase 3 efficacy and safety results. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Pooled efficacy results of estetrol/drospirenone combined oral contraception phase 3 trials. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Clinical experiences with drospirenone: from reproductive to postmenopausal years. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Signal detection of drospirenone-containing oral contraceptives: a disproportionality analysis using the Korea Adverse Event Reporting System Database, 2008-2017. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

YAZ and the novel progestin drospirenone. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Safety, influence on the endometrium, sonographic changes and bleeding profile after 13 cycles with the new drospirenone only pill (DOP) for contraception. [2021]

10. England pubmed.ncbi.nlm.nih.gov

A 1-year pharmacokinetic investigation of a novel oral contraceptive containing drospirenone in healthy female volunteers. [2019]

11. Spain pubmed.ncbi.nlm.nih.gov

Drospirenone/ethinyl estradiol. [2017]

12. England pubmed.ncbi.nlm.nih.gov

Oestrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and a review of the literature. [2022]

13. Italy pubmed.ncbi.nlm.nih.gov

Drospirenone 4 mg in a 24/4 regimen maintains inhibition of ovulation even after a 24-h delay pill intake - Pharmacological aspects and comparison to other progestin-only pills. [2022]